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Chemistry

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Also known as: Trolamine, 102-71-6, 2,2',2''-nitrilotriethanol, Sterolamide, Tris(2-hydroxyethyl)amine, Daltogen
Molecular Formula
C6H15NO3
Molecular Weight
149.19  g/mol
InChI Key
GSEJCLTVZPLZKY-UHFFFAOYSA-N
FDA UNII
9O3K93S3TK

Triethanolamine
Triethanolamine is a metabolite found in the aging mouse brain.
1 2D Structure

Triethanolamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[bis(2-hydroxyethyl)amino]ethanol
2.1.2 InChI
InChI=1S/C6H15NO3/c8-4-1-7(2-5-9)3-6-10/h8-10H,1-6H2
2.1.3 InChI Key
GSEJCLTVZPLZKY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C(CO)N(CCO)CCO
2.2 Other Identifiers
2.2.1 UNII
9O3K93S3TK
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2,2',2''-nitrilotriethanol

2. Triethanolamine Acetate

3. Triethanolamine Citrate

4. Triethanolamine Citrate (1:1)

5. Triethanolamine Copper Salt

6. Triethanolamine Hydrochloride

7. Triethanolamine Iodohydrate

8. Triethanolamine Maleate

9. Triethanolamine Phosphate

10. Triethanolamine Sulfate

11. Triethanolamine Sulfate (2:1)

12. Triethanolamine Sulfite (1:1)

13. Triethanolamine Tartrate (1:1), (r-(r*,r*))-isomer

14. Triethanolamine Titanium Salt

15. Triethanolammonium Chloride

16. Trolamine

2.3.2 Depositor-Supplied Synonyms

1. Trolamine

2. 102-71-6

3. 2,2',2''-nitrilotriethanol

4. Sterolamide

5. Tris(2-hydroxyethyl)amine

6. Daltogen

7. Nitrilotriethanol

8. Triethylolamine

9. Trihydroxytriethylamine

10. Thiofaco T-35

11. Triethanolamin

12. Sting-kill

13. Ethanol, 2,2',2''-nitrilotris-

14. Tri(hydroxyethyl)amine

15. Tris(beta-hydroxyethyl)amine

16. Nitrilo-2,2',2''-triethanol

17. Sodium Isa

18. Alkanolamine 244

19. Teoa

20. Tea (amino Alcohol)

21. 2,2',2''-nitrilotris(ethanol)

22. Nitrilotris(ethanol)

23. 2-[bis(2-hydroxyethyl)amino]ethanol

24. Tris(hydroxyethyl)amine

25. Triethanolamin-ng

26. H3tea

27. Triaethanolamin-ng

28. Trolamine [inn]

29. 2,2',2-nitrilotriethanol

30. N(ch2ch2oh)3

31. Mobisyl

32. 2,2',2''-nitrilotrisethanol

33. Trola

34. Triethanolamine Homopolymer

35. 2,2',2''-trihydroxytriethylamine

36. Poly(triethanolamine) Ether

37. Trihydroxyethylamine

38. Trolamine (nf)

39. Trolamine [nf]

40. Mfcd00002855

41. Nsc 36718

42. Mobisy (tn)

43. Triethylamine, 2,2',2''-trihydroxy-

44. Triethanolamine Condensate Polymer

45. Ethanol, 2,2',2''-nitrilotri-

46. Ethanol, 2,2',2''-nitrilotris-, Homopolymer

47. Nsc-36718

48. Nciopen2_004601

49. 2,2',2"-nitrilotriethanol

50. 2-[bis(2-hydroxyethyl)amino]ethan-1-ol

51. 9o3k93s3tk

52. 2,2',2-nitrilotris(ethanol)

53. Chebi:28621

54. 2,2',2''-nitrilotris[ethanol]

55. Ncgc00159411-02

56. Dsstox_cid_1392

57. Tri-beta-hydroxy Ethylamine

58. Dsstox_rid_76134

59. Dsstox_gsid_21392

60. 64114-46-1

61. Caswell No. 886

62. Biafine

63. Tris(2-hydroxyethyl) Amine

64. Cas-102-71-6

65. Ccris 606

66. Hsdb 893

67. Triethanol Amine

68. Einecs 203-049-8

69. 2,2,2-nitrilotriethanol

70. Epa Pesticide Chemical Code 004208

71. Unii-9o3k93s3tk

72. Ethanolamines

73. 2,2',2'-nitrilotriethanol

74. Cerumenex

75. Alkano

76. Mobisy

77. Ai3-01140

78. Ethanol, 2,2',2'-nitrilotris-

79. Triethanolamine 85%

80. Triethanolamine 99%

81. Mobisyl (salt/mix)

82. Triethanolamine, Usp

83. Trolamine [ii]

84. Trolamine [hsdb]

85. Tris(b-hydroxyethyl)amine

86. Trolamine [vandf]

87. 2,2''-nitrilotriethanol

88. Bmse000379

89. Trolamine [mart.]

90. Ec 203-049-8

91. Nitrilo-2,2''-triethanol

92. Schembl1146

93. Trolamine [who-dd]

94. Triethanolamine [mi]

95. Oprea1_614203

96. Tris-(2-hydroxyethyl)-amine

97. Wln: Q2n2q2q

98. Tris(beta -hydroxyethyl)amine

99. 2,2''-nitrilotris[ethanol]

100. Bidd:er0261

101. Triethanolamine [iarc]

102. Triethanolamine [inci]

103. Ethanol,2',2''-nitrilotri-

104. Triethanolamine [vandf]

105. Tris(.beta.-hydroxyethyl)amine

106. Chembl446061

107. Ethanol,2',2''-nitrilotris-

108. Triethanolamine, Lr, >=99%

109. 2,2',2'-nitrilotris-ethanol

110. 2,2'2''-nitrilotris-ethanol

111. Trolamine [ep Impurity]

112. 2,2', 2''-nitrilotriethanol

113. 2,2',2quot -nitrilotriethanol

114. Dtxsid9021392

115. Trolamine [ep Monograph]

116. 2,2',2''-nitrilotri-ethanol

117. 2,2',2''-nitrilotris-ethanol

118. Nitrilo-2,2',2quot -triethanol

119. Triethanolamine, P.a., 99.0%

120. Triethanolamine, Ar, >=99.5%

121. Zinc896409

122. Triethanolamine 99% Reagent Grade

123. Triethylamine,2',2''-trihydroxy-

124. Adal1017515

125. Hy-b1809

126. Nsc36718

127. Tox21_113166

128. Tox21_202062

129. Tox21_300527

130. Triethanolamine, >=99.0% (gc)

131. 2,2',2''-trihydroxy-triethylamine

132. Stl264185

133. Triethanolamine, Reagent Grade, 98%

134. Akos000119997

135. Cs-5859

136. Db13747

137. 637-39-8 (unspecified Hydrochloride)

138. Smp2_000190

139. Tea, 0.2m Buffer Solution, Ph 7.0

140. Tea, 0.2m Buffer Solution, Ph 8.0

141. Ncgc00159411-03

142. Ncgc00159411-04

143. Ncgc00159411-05

144. Ncgc00159411-06

145. Ncgc00254460-01

146. Ncgc00259611-01

147. 7376-31-0 (unspecified Sulfate Salt)

148. Bp-21029

149. Ls-13235

150. Triethanolamine, Usp, 99.0-107.4%

151. 7376-31-0 (unspecified Sulphate Salt)

152. Triethanolamine, Bioultra, >=99.5% (gc)

153. Triethanolamine, Analytical Reference Material

154. Triethanolamine, Saj First Grade, >=98.0%

155. C06771

156. D00215

157. Triethanolamine, Jis Special Grade, >=98.0%

158. Triethanolamine, Puriss. P.a., >=99% (gc)

159. Triethanolamine, Vetec(tm) Reagent Grade, 97%

160. Q424314

161. Sr-01000944572

162. J-525067

163. Sr-01000944572-1

164. B886ef22-aca3-4597-9c73-a087e02f54a7

165. Trolamine, European Pharmacopoeia (ep) Reference Standard

166. Trolamine, United States Pharmacopeia (usp) Reference Standard

167. Triethanolamine, Puriss., Meets Analytical Specification Of Nf, >=99% (gc)

168. Trolamine, Pharmaceutical Secondary Standard; Certified Reference Material

169. Triethanolamine, Pharmagrade, Usp, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production.

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 149.19 g/mol
Molecular Formula C6H15NO3
XLogP3-1
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count6
Exact Mass149.10519334 g/mol
Monoisotopic Mass149.10519334 g/mol
Topological Polar Surface Area63.9 Ų
Heavy Atom Count10
Formal Charge0
Complexity55.7
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

/EXPL THER/ This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL). From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found. The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.

PMID:1664851 Elliott EA et al; J Clin Oncol 24 (13): 2092-7 (2006)


Triethanolamine salicylate has also been used as a nonsteroidal anti-inflammatory. Triethanolamine USP is also used as a pharmaceutical adjuvant or alkalizing agent, and in combination with a fatty acid (e.g., oleic acid, stearic acid) as an emulsifier (the triethanolamine soap formed lowers the surface tension of the aqueous phase). /Triethanolamine salicylate/

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V4 785


4.2 Minimum/Potential Fatal Human Dose

2= Slightly toxic: Probable oral lethal dose (human) 5-15 g/kg, between 1 pint & 1 qt for 70 kg person (150 lb).

Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-106


4.3 Drug Indication

Trolamine is used as an alkalizing agent, surfactant, and counter-ion in cosmetic and pharmaceutical formulations. It is not considered to be an active pharmacological ingredient and so has no official indication.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Acts as a surfactant or alkalizing agent to aid in emulsification and solubilizing of compounds or in raising the pH of a solution


5.2 ATC Code

D - Dermatologicals

D03 - Preparations for treatment of wounds and ulcers

D03A - Cicatrizants

D03AX - Other cicatrizants

D03AX12 - Trolamine


5.3 Absorption, Distribution and Excretion

Absorption

Dermal absorption of trolamine increases with the dose. This has been found to range from 19-28% in rats with doses of 68-276 mg/kg in 190 L of acetone without occlusion and from 60-80% in mice with doses of 79-1120 mg/kg in the same volume of acetone.


Route of Elimination

When orally administered to rats, the 53% of the trolamine dose was found to be excreted in the urine and 20% in the feces. 98% was excreted in the urine with intravenous administration.


The elimination of 14(C)triethanolamine from the blood of mice administered 1.0 mg/kg bw iv showed first-order biphasic kinetics with a rapid (0.58-hr half life) and a slow phase (10.2-hr half-life). The slow phase half-lives for elimination of triethanolamine in mice after dermal exposure to 1000 and 2000 mg/kg bw in acetone were 9.7 hr and 18.6 hr. Skin absorption rates (as blood concentration-time curves) after dermal application of aqueous and neat 14(C)triethanolamine to mouse skin (2000 mg/kg bw, enclosed by a glass ring) showed no significant change with the use of water as the vehicle.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V77 389 (2000)


In a dermal pharmacokinetic study, (14)C-triethanolamine was absorbed more slowly and less extensively in F344 rats than in C3H/HeJ mice. 48 hr after dermal application of (14)C-triethanolamine to mice (1,000 mg/kg dose), about 60% of the radioactivity was recovered from the urine and about 20% was recovered in the feces; less than 10% of the radioactivity was found in skin at the site of application. It was concluded that triethanolamine does not undergo extensive biotransformation in mice, since greater than 95% of the radioactivity recovered from the urine was identified as the parent compound.

Snyder, R. (ed.). Ethel Browning's Toxicity and Metabolism of Industrial Solvents. 2nd ed. Volume II: Nitrogen and Phosphorus Solvents. Amsterdam-New York-Oxford: Elsevier, 1990., p. 443


Triethanolamine was rapidly absorbed in orally dosed rats, and subsequently excreted mainly as unchanged parent compound in the urine. 24 hr after oral administration of triethanolamine (single dose of 2-3 mg/kg), 53% and 20% of the administered dose was recovered as the parent compound in the urine and feces, respectively.

Snyder, R. (ed.). Ethel Browning's Toxicity and Metabolism of Industrial Solvents. 2nd ed. Volume II: Nitrogen and Phosphorus Solvents. Amsterdam-New York-Oxford: Elsevier, 1990., p. 443


...After single oral administration to male rats, the excretion ratios of unchanged /triethanolamine/ in the urine and feces for one day were 53% and 20% of the dose, respectively.

Kohri N et al; Arch Pract Pharm 42: 342-348 (1982)


For more Absorption, Distribution and Excretion (Complete) data for TRIETHANOLAMINE (8 total), please visit the HSDB record page.


5.4 Metabolism/Metabolites

Trolamine is excreted mostly as the unchanged compound. No diethanolamine or ethanolamine has been found. Very small amounts of trolamine glucuronide have been detected but not quantified.


...N-nitrosodiethanolamine, known carcinogen and mutagen, ...may not be the main mutagenic product.

PMID:100210 Hoshino H, Tanooka H; Cancer Res 38 (11): 3918-21 (1978)


After multiple oral administration to male and female rats, triethanolamine was mainly excreted unchanged. The urinary and fecal excretion ratio of unchanged triethanolamine remained constant throughout the treatment period (for five to six days) in both males and females. A small amount of triethanolamine (1.4-2.7%) was excreted as glucuronide conjugates.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V77 390 (2000)


The biotransformation of 14(C)triethanolamine to monoethanolamine and diethanolamine was specifically investigated in mice after both intravenous and dermal treatments. Neither of the hypothetical metabolites was detected in urine (by mass spectral analysis), whereas more than 95% of the radioactivity detected in urine was identified as unchanged triethanolamine. In vitro, triethanolamine had an inhibitory effect on the incorporation of 32(P)phosphate into phospholipids from rabbit and human tissues. Cytochrome P450 monooxygenasedependent oxidative N-dealkylation of triethanolamine does occur in microorganisms, with formation of diethanolamine, ethanolamine and glyoxylate as reaction products.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V77 389 (2000)


To determine potential nitrosation of triethanolamine (TEA) to N-nitrosodiethanolamine (NDELA) at different physiological conditions of the GI tract, in vitro NDELA formation was examined in aqueous reaction mixtures at several pHs (2-10) adjusted with acetic, sulfuric or hydrochloric acids or in cultures of mouse cecal microflora incubated. In vivo NDELA formation was also determined in blood, ingesta, and urine of female B6C3F1 mice after repeated dermal, most relevant human route, or single oral exposure to 1000 mg/kg TEA in the presence of high oral dosages of NaNO(2). Appropriate diethanolamine (DEA) controls were included to account for this impurity in the TEA used. Samples were analyzed for NDELA using GC/MS. The highest degree of nitrosation of TEA to NDELA (approximately 3%) was observed in the in vitro cultures at pH 4 and acetic acid with lower amounts obtained using sulphuric acid ( pproximately 1.3%) and hydrochloric acid (approximately 1.2%). At pH 7, <1% of the TEA was nitrosated to NDELA and at pH 2 (HCl) or pH 10 (NaOH) no NDELA was found above the limit of detection. In incubated cultures containing cecal microflora and nutrient broth, only 0.68% of TEA was nitrosated to NDELA. No NDELA was formed in rats repeatedly dermally dosed with TEA at the limits of detection in blood (0.001 ug/mL, ppm), ingesta (0.006 ug/mL, ppm), and urine (0.47 ug/mL, ppm). Levels of NDELA measured in blood and ingesta after a single oral dose of TEA and NaNO(2) were less than those in DEA controls. These findings in toto confirm the lack of any significant formation of NDELA from TEA in vivo.

PMID:15905009 Saghir SA et al; Regul Toxicol Pharmacol 43 (1): 10-8 (2005)


For more Metabolism/Metabolites (Complete) data for TRIETHANOLAMINE (6 total), please visit the HSDB record page.


5.5 Biological Half-Life

The elimination of 14(C)triethanolamine from the blood of mice administered 1.0 mg/kg bw intravenously showed first-order biphasic kinetics with a rapid (0.58-hr half life) and a slow phase (10.2-hr half-life). The slow phase half-lives for elimination of triethanolamine in mice after dermal exposure to 1000 and 2000 mg/kg bw in acetone were 9.7 hr and 18.6 hr.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V77 389 (2000)


The blood half-life of triethanolamine equivalents after iv injection (1 mg/kg) or dermal application (1000 mg/kg) of (14)C-triethanolamine in mice was about 9.5 hr.

Snyder, R. (ed.). Ethel Browning's Toxicity and Metabolism of Industrial Solvents. 2nd ed. Volume II: Nitrogen and Phosphorus Solvents. Amsterdam-New York-Oxford: Elsevier, 1990., p. 443


5.6 Mechanism of Action

As an amine, trolamine is capable of accepting a hydrogen to form hydroxide and a conjugate acid. This raises the pH of the solution. As a surfactant, it can lower the interfacial tension in a mixture or solution to prevent separation of emulsions or precipitation of a compound out of solution.


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Laboratorio Syntex S.A

Argentina

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triethanolamine

About the Company : Syntex is an Argentine company that elaborates active ingredients from biological and semi-synthetic origins for Human and Veterinary Pharmaceutical Industry since 1935. We work wi...

Syntex is an Argentine company that elaborates active ingredients from biological and semi-synthetic origins for Human and Veterinary Pharmaceutical Industry since 1935. We work with the implementation of technological development that allows the obtaining of derivatives and more ecient evolutions for new uses and applications in Diagnose, Human and Veterinary Medicine.
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","customerCountry":"INDIA","quantity":"23000.00","actualQuantity":"23","unit":"MTS","unitRateFc":"1300","totalValueFC":"30246.3","currency":"USD","unitRateINR":"110305","date":"19-Aug-2024","totalValueINR":"2537015","totalValueInUsd":"30246.3","indian_port":"JNPT","hs_no":"29221500","bill_no":"5122175","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"LIMITED555\/1 ENERGY COMPLEX BUILDING A,14TH-18TH FLOOR VIBHAVADI RANGSIT ROAD,CHATUCHAK,CHATUCHAK,BANGKOK THAILAND","customerAddress":"145, A, MITTAL TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"TRIETHANOLAMINE (ISO TANK CONTAINER)","address":"D\/10, R NO.3, BHADRAN NAGAR, NR","city":"WEST, MUMBAI, MAHARASHTRA","supplier":"PETROCHEM MIDDLE EAST ","supplierCountry":"TAIWAN","foreign_port":"JEBEL ALI","customer":"SHREE LAKSHMI CORPORATION","customerCountry":"INDIA","quantity":"21450.00","actualQuantity":"21450","unit":"KGS","unitRateFc":"1.3","totalValueFC":"27123","currency":"USD","unitRateINR":"106.1","date":"22-Aug-2024","totalValueINR":"2275040.63","totalValueInUsd":"27123","indian_port":"JNPT","hs_no":"29221500","bill_no":"5192569","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JEBEL ALI","supplierAddress":"P.O.BOX 17028 JEBEL ALI, DUBAI., UNITED ARAB EMIRATESSDNF UNITED ARAB EMIRATES","customerAddress":"D\/10, R NO.3, BHADRAN NAGAR, NR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"TRIETHANOLAMINE (ISO TANK CONTAINER)","address":"D\/10, R NO.3, BHADRAN NAGAR, NR","city":"WEST, MUMBAI, MAHARASHTRA","supplier":"PETROCHEM MIDDLE EAST ","supplierCountry":"TAIWAN","foreign_port":"JEBEL ALI","customer":"SHREE LAKSHMI CORPORATION","customerCountry":"INDIA","quantity":"21560.00","actualQuantity":"21560","unit":"KGS","unitRateFc":"1.3","totalValueFC":"27262.1","currency":"USD","unitRateINR":"106.1","date":"22-Aug-2024","totalValueINR":"2286707.5","totalValueInUsd":"27262.1","indian_port":"JNPT","hs_no":"29221500","bill_no":"5190303","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JEBEL ALI","supplierAddress":"P.O.BOX 17028 JEBEL ALI, DUBAI., UNITED ARAB EMIRATESSDNF UNITED ARAB EMIRATES","customerAddress":"D\/10, R NO.3, BHADRAN NAGAR, NR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"TRIETHANOLAMINE 99 % (NOT FOR MEDICINAL USE)","address":"C- 501, REMI BIZCOURT, VEERA DESAI ROAD, PLOT NO. 9,","city":"MUMBAI","supplier":"THE DOW CHEMICAL COMPANY","supplierCountry":"SAUDI ARABIA","foreign_port":"JEBEL ALI","customer":"SUPERIX SPECIALTY PRIVATE LIMITED","customerCountry":"INDIA","quantity":"18400.00","actualQuantity":"18400","unit":"KGS","unitRateFc":"1.7","totalValueFC":"32014.5","currency":"USD","unitRateINR":"145.9","date":"23-Aug-2024","totalValueINR":"2685332.8","totalValueInUsd":"32014.5","indian_port":"JNPT","hs_no":"29221500","bill_no":"5216608","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SAUDI ARABIA","selfForZScoreResived":"Non Pharma","supplierPort":"JEBEL ALI","supplierAddress":"BCW JAFZA VIEW 18 JEBEL ALI FREE ZONE , DUBAISDNF UNITED ARAB EMIRATES","customerAddress":"C- 501, REMI BIZCOURT, VEERA DESAI ROAD, PLOT NO. 9,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"TRIETHANOLAMINE (TEA) FOR CAPTIVE USE IN DRY MIX PLANT PO. NO. 8C\/B02\/8000109084 TANK CONTAINER","address":"B- WING, AHURA CENTRE, 2ND FLOOR,","city":"ANDHERI-(E), MUMBAI, MAHARASHTRA.","supplier":"SABIC ASIA PACIFIC ","supplierCountry":"SAUDI ARABIA","foreign_port":"JUBAIL","customer":"ULTRATECH CEMENT LIMITED","customerCountry":"INDIA","quantity":"94720.00","actualQuantity":"94.72","unit":"MTS","unitRateFc":"1280","totalValueFC":"122670.3","currency":"USD","unitRateINR":"108629.7","date":"28-Aug-2024","totalValueINR":"10289407.23","totalValueInUsd":"122670.3","indian_port":"JNPT","hs_no":"29221500","bill_no":"5288285","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JUBAIL","supplierAddress":"ONE TEMASEK AVENUE, NO. 06-01 MILLENIA TOWER SINGAPORE 039192 SINGAPORE SINGAPORE","customerAddress":"B- WING, AHURA CENTRE, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724956200,"product":"TRIETHANOLAMINE","address":"22,GROUND FLOOR,SHANTINIKETAN,8,","city":"KOLKATA,W.B.","supplier":"PETRONAS CHEMICALS MARKETING ","supplierCountry":"MALAYSIA","foreign_port":"KERTEH TERMINAL","customer":"KLJ RESOURCES LTD","customerCountry":"INDIA","quantity":"471997.00","actualQuantity":"471.997","unit":"MTS","unitRateFc":"1100","totalValueFC":"525288.1","currency":"USD","unitRateINR":"93348.9","date":"30-Aug-2024","totalValueINR":"44060397","totalValueInUsd":"525288.1","indian_port":"Kandla","hs_no":"29221500","bill_no":"5336842","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KERTEH TERMINAL","supplierAddress":"LEVEL 34, TOWER 1, PETRONASTWIN TOWERS, KUALA LUMPURCITY CENTRE, 50088,KUALA LUMPUR, MALAYSIA","customerAddress":"22,GROUND FLOOR,SHANTINIKETAN,8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"TRIETHANOLAMINE 99% (NOT FOR MEDICINAL USE)","address":"C- 501, REMI BIZCOURT, VEERA DESAI ROAD, PLOT NO. 9,","city":"MUMBAI","supplier":"THE DOW CHEMICAL COMPANY","supplierCountry":"SAUDI ARABIA","foreign_port":"JEBEL ALI","customer":"SUPERIX SPECIALTY PRIVATE LIMITED","customerCountry":"INDIA","quantity":"18400.00","actualQuantity":"18400","unit":"KGS","unitRateFc":"1.7","totalValueFC":"32014.5","currency":"USD","unitRateINR":"145.9","date":"31-Aug-2024","totalValueINR":"2685332.8","totalValueInUsd":"32014.5","indian_port":"Madras Sea","hs_no":"29221500","bill_no":"5361787","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SAUDI ARABIA","selfForZScoreResived":"Non Pharma","supplierPort":"JEBEL ALI","supplierAddress":"DUBAI BRANCHBCW JAFZA VIEW 18,DUBAISDNF AE","customerAddress":"C- 501, REMI BIZCOURT, VEERA DESAI ROAD, PLOT NO. 9,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"TRIETHANOLAMINE 99 (TEA99)","address":"PLOT NO3 21,PANOLI","city":"ANKLESHWAR,GUJARAT","supplier":"PTT GLOBAL CHEMICAL PUBLIC COMPANY LIMITED","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"INDORAMA VENTURES OXIDES ","customerCountry":"INDIA","quantity":"52800.00","actualQuantity":"52800","unit":"KGS","unitRateFc":"1.4","totalValueFC":"72105.5","currency":"USD","unitRateINR":"114.5","date":"31-Aug-2024","totalValueINR":"6048108","totalValueInUsd":"72105.5","indian_port":"JNPT","hs_no":"29221500","bill_no":"5357246","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"555\/1 ENERGY COMPLEX, BUILDING A, 18TH FLOOR, VIBHAVADI RANGSIT ROAD,CHATUCHAK, BANGKOK TH","customerAddress":"PLOT NO3 21,PANOLI"}]
22-Jan-2021
31-Aug-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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FDF Dossiers

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01

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Ireland
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TROLAMINE POLYPEPTIDE OLEATE CONDENSATE

Brand Name : CERUMENEX

Dosage Form : SOLUTION/DROPS;OTIC

Dosage Strength : 10%

Packaging :

Approval Date : 1982-01-01

Application Number : 11340

Regulatory Info : DISCN

Registration Country : USA

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01

DKSH

Switzerland
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  • EDQM
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Topical, Parenteral

Category : Solubilizers, Topical

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DKSH

Switzerland
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Topical, Parenteral

Category : Solubilizers, Topical

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Direct Compression

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01

SPI Pharma

U.S.A
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  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Direct Compression

Brand Name : DC SIM 100

Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.

Pharmacopoeia Ref : NA

Technical Specs : PSD D50: 50

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DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 1237

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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REF. STANDARDS & IMPURITIES

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USP

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USP

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U.S.A
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Others

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01

USP

U.S.A
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USP

U.S.A
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Trolamine (3 mL) (International Restricted Sa...

CAS Number : 102-71-6

Quantity Per Vial : 3

Sale Unit : ml

Price : $265.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1696958 / F0D120

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02

USP

U.S.A
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USP

U.S.A
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Ecamsule Triethanolamine (200 mg)

CAS Number : 92841-53-7

Quantity Per Vial : 200

Sale Unit : mg

Price : $257.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1231604 / F0H444

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ANALYTICAL

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Analytical Methods

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01

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Luxepack
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YMC

Japan
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YMC-Triart C18

Product Code : TA12SP9-0502PT

Classification : DrugsC Metabolites

Product Characteristics : F131125A

Category :

Description :

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Luxepack
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YMC

Japan
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YMC-Triart C18

Product Code : TA12S05-1503WT

Classification : DrugsC Metabolites

Product Characteristics : F131125A

Category :

Description :

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