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Chemistry

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Also known as: Orthoboric acid, 10043-35-3, Boracic acid, Borofax, Boron hydroxide, Boron trihydroxide
Molecular Formula
BH3O3
Molecular Weight
61.84  g/mol
InChI Key
KGBXLFKZBHKPEV-UHFFFAOYSA-N
FDA UNII
R57ZHV85D4

Boric Acid
Boric Acid is a weakly acidic hydrate of boric oxide with mild antiseptic, antifungal, and antiviral properties. The exact mechanism of action of boric acid is unknown; generally cytotoxic to all cells. It is used in the treatment of yeast infections and cold sores.
1 2D Structure

Boric Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
boric acid
2.1.2 InChI
InChI=1S/BH3O3/c2-1(3)4/h2-4H
2.1.3 InChI Key
KGBXLFKZBHKPEV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
B(O)(O)O
2.2 Other Identifiers
2.2.1 UNII
R57ZHV85D4
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Boron Oxide Hydroxide

2. Orthoboric Acid

2.3.2 Depositor-Supplied Synonyms

1. Orthoboric Acid

2. 10043-35-3

3. Boracic Acid

4. Borofax

5. Boron Hydroxide

6. Boron Trihydroxide

7. Three Elephant

8. Boric Acid (bh3o3)

9. Basilit B

10. Trihydroxyborane

11. Trihydroxyborone

12. 11113-50-1

13. Boric Acid (h3bo3)

14. Flea Prufe

15. Super Flea Eliminator

16. Orthoboric Acid (b(oh)3)

17. Orthoborsaeure

18. Borsaeure

19. Borsaure

20. Acidum Boricum

21. Nci-c56417

22. Dr.'s 1 Flea Terminator Dt

23. Boric Acid (van)

24. Bluboro

25. Dr.'s 1 Flea Terminator Dfpbo

26. Dr.'s 1 Flea Terminator Df

27. Collyrium Eye Wash

28. Dr.'s 1 Flea Terminator Dtpbo

29. B(oh)3

30. Boricum Acidum

31. Trihydroxidoboron

32. Ant Flip

33. Homberg's Salt

34. Mfcd00011337

35. Nsc 81726

36. Boric Acid (tn)

37. (10b)orthoboric Acid

38. Nsc-81726

39. Ins No.284

40. R57zhv85d4

41. Chebi:33118

42. Ins-284

43. [b(oh)3]

44. Boric Acid (h(sub 3)bo(sub 3))

45. Ncgc00090745-02

46. Optibor

47. Dsstox_cid_194

48. Orthboric Acid

49. E-284

50. Kjel-sorb™ Solution

51. Dsstox_rid_75425

52. Dsstox_gsid_20194

53. Borsaure [german]

54. Caswell No. 109

55. Boron, Reference Standard Solution

56. Kjel-sorb

57. Kill-off

58. Ortho-boric Acid

59. Boric Acid [usan:jan]

60. Hydrogen Orthoborate

61. Bo3

62. Ccris 855

63. Niban Granular Bait

64. Cas-10043-35-3

65. Hsdb 1432

66. Boric Acid [jan:nf]

67. Boric Acid, Acs

68. Einecs 233-139-2

69. Epa Pesticide Chemical Code 011001

70. Orthoboric Acid (h3bo3)

71. Unii-r57zhv85d4

72. Orthoborc Acd

73. Ai3-02406

74. Boric Acid, Powder

75. Bluboro (salt/mix)

76. Boric Acid, Granular

77. Boric Acid Acs Grade

78. Boric Acid, Puratronic?

79. Wln: Qbqq

80. Boric Acid [ii]

81. Boric Acid [mi]

82. Boric Acid, Acs Reagent

83. Boric Acid [jan]

84. Heptaoxotetra-borate(2-)

85. Bmse000941

86. Boric Acid (jp15/nf)

87. Boric Acid (jp17/nf)

88. Boric Acid [inci]

89. Acidum Boricum (salt/mix)

90. Ec 233-139-2

91. Boric Acid [vandf]

92. Boric Acid, Nf/usp Grade

93. H3bo3

94. Boric Acid [mart.]

95. Boric Acid [usp-rs]

96. Boric Acid [who-dd]

97. Boric Acid, Biochemical Grade

98. Bidd:er0252

99. Boracic Acid, Orthoboric Acid

100. Boricum Acidum [hpus]

101. Chembl42403

102. Boric Acid Electrophoresis Grade

103. Collyrium Eye Wash (salt/mix)

104. Dtxsid1020194

105. Bdbm39817

106. Kgbxlfkzbhkpev-uhfffaoysa-

107. Boric Acid [ep Impurity]

108. Boric Acid [ep Monograph]

109. Boric Acid, 99.9% Metals Basis

110. Bcp21018

111. Boric Acid, 99.99% Metals Basis

112. Boric Acid, Bioxtra, >=99.5%

113. Nsc81726

114. Einecs 237-478-7

115. Tox21_111004

116. Tox21_202185

117. Tox21_301000

118. 1332-77-0 (di-potassium Salt)

119. Bc-140

120. Stl445672

121. Boric Acid, 99.998% Metals Basis

122. Akos015833571

123. Zinc245189278

124. Boric Acid, Acs Reagent, >=99.5%

125. Db11326

126. 11113-50-1;boric Acid;boracic Acid

127. Boric Acid, 99.97% Trace Metals Basis

128. Boric Acid, Usp, 99.5-100.5%

129. Ncgc00090745-01

130. Ncgc00090745-03

131. Ncgc00090745-04

132. Ncgc00090745-05

133. Ncgc00254902-01

134. Ncgc00259734-01

135. Boric Acid, Crude Natural, Containing Not More Than 85 Per Cent Ofh3bo3 Calculated On The Dry Weight

136. Boric Acid, Reagentplus(r), >=99.5%

137. Bp-13473

138. Boric Acid, 99.999% Trace Metals Basis

139. Boric Acid, Saj First Grade, >=99.5%

140. Boric Acid, For Electrophoresis, >=99.5%

141. Boric Acid, Jis Special Grade, >=99.5%

142. B7305

143. Boric Acid, Vetec(tm) Reagent Grade, 98%

144. Ft-0623166

145. Ft-0623167

146. Boric Acid, Tablet, 1 G Boric Acid Per Tablet

147. D01089

148. A800201

149. Q187045

150. J-000132

151. J-523836

152. Boric Acid, >=99.5%, Suitable For Amino Acid Analysis

153. Boric Acid, Nist(r) Srm(r) 951a, Isotopic Standard

154. Boric Acid, Nist(r) Srm(r) 973, Acidimetric Standard

155. Boric Acid, Bioultra, For Molecular Biology, >=99.5% (t)

156. Boric Acid, United States Pharmacopeia (usp) Reference Standard

157. Boric Acid, Cell Culture Tested, Plant Cell Culture Tested, >=99.5%

158. Boric Acid, Biotechnology Performance Certified, >=99.5% (titration), Cell Culture Tested

159. Boric Acid, P.a., Acs Reagent, Reag. Iso, Reag. Ph. Eur., 99.5-100.5%

160. Boron Standard Solution, 1 Mg/ml B, Suitable For Atomic Absorption Spectrometry, 1000 Ppm B

161. Buffer Solution, Ph 11.00 (?0.01 At 25?c), No Color, Specpure?, Nist Traceable

162. Boric Acid, Bioreagent, For Molecular Biology, Suitable For Cell Culture, Suitable For Plant Cell Culture, >=99.5%

163. Boric Acid, Puriss. P.a., Acs Reagent, Reag. Iso, Reag. Ph. Eur., Buffer Substance, >=99.8%

164. Boric Acid, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Nf, 99.5-100.5%, Powder

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 61.84 g/mol
Molecular Formula BH3O3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count3
Rotatable Bond Count0
Exact Mass62.0175241 g/mol
Monoisotopic Mass62.0175241 g/mol
Topological Polar Surface Area60.7 Ų
Heavy Atom Count4
Formal Charge0
Complexity8
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

/Former use:/ The substance is included in rectal suppositories for hemorrhoids ...

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 971


Aqueous solutions of boric acid are used topically for ophthalmic irrigation to cleanse, refresh, and soothe irritated eyes. Aqueous solutions of boric acid also are used for removal of loose foreign material, air pollutants (e.g., smog, pollen), or chlorinated water.

American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011


Boric acid, borates and perborates have been used as mild antiseptics or bacteriostats in eyewashes, mouthwashes, burn dressings, and diaper rash powders; however, the effectiveness of boric acid has largely been discredited.

Seiler, H.G., H. Sigel and A. Sigel (eds.). Handbook on the Toxicity of Inorganic Compounds. New York, NY: Marcel Dekker, Inc. 1988., p. 131


MEDICATION (VET): Antibacterial and antifungal. Used chiefly in aqueous solutions or powders for external use.

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 2006., p. 218


A double-blind comparison was made of the use of 14 daily intravaginal gelatin capsules containing 600 mg of boric acid powder versus the use of identical capsules containing 100,000 U nystatin diluted to volume with cornstarch for the treatment of vulvovaginal candidiasis albicans. Cure rates for boric acid were 92% at 7 to 10 days after treatment and 72% at 30 days, whereas the nystatin cure rates were 64% at 7 to 10 days and 50% at 30 days. The speed of alleviation of signs and symptoms was similar for the two drugs. There were no untoward side effects, and cervical cytologic features were not affected.

PMID:7282789 Van Slyke KK et al; Am J Obstet Gynecol 141 (2): 145-8 (1981)


4.2 Drug Warning

... The chronic use of boric acid in rectal suppositories and in vaginal deodorants carries the risk of intoxication.

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 971


Borax and boric acid used in powders and ointments have resulted in serious poisonings and death.

Seiler, H.G., H. Sigel and A. Sigel (eds.). Handbook on the Toxicity of Inorganic Compounds. New York, NY: Marcel Dekker, Inc. 1988., p. 135


An outbreak of an illness in a newborn nursery consisting of vomiting, diarrhea, dehydration, and exfoliative dermatitis was mistakenly thought to be due to an infectious agent because Staphylococcus aureus was cultured from the nose, throat, and feces in two patients. The clinical picture was similar to Ritter's disease. However, because S. aureus was not found in other hospital cultures, boric acid toxicity was subsequently considered. It was discovered as a contaminant of the infant formula. Three infants died.

Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 1323


Boric acid enhanced action of hypnotics, but devoid of activity itself.

PMID:4440819 Pham Huu Chanh et al; Agressologie 15 (1): 61-72 (1974)


Patients using boric acid ophthalmic solutions should be advised to consult a physician if ocular pain or visual changes occur, they experience continued ocular redness or irritation, or the condition worsens or persists. Patients with open wounds in or near the eyes should be advised to seek immediate medical treatment.

American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011


4.3 Minimum/Potential Fatal Human Dose

The fatal dose /in humans/ is thought to be 2000-3000 mg for infants, 5000-6000 mg for children, and 15,000-20,000 mg for adults.

Krieger, R. (ed.). Handbook of Pesticide Toxicology. Volume 2, 2nd ed. 2001. Academic Press, San Diego, California., p. 1414


4.4 Drug Indication

No FDA- or EMA-approved therapeutic indications on its own.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Boric acid exhibits minimal bacteriostatic and antifungal activities. Boric acid is likely to mediate antifungal actions at high concentrations over prolonged exposures.


5.2 MeSH Pharmacological Classification

Insecticides

Pesticides designed to control insects that are harmful to man. The insects may be directly harmful, as those acting as disease vectors, or indirectly harmful, as destroyers of crops, food products, or textile fabrics. (See all compounds classified as Insecticides.)


5.3 ATC Code

S - Sensory organs

S02 - Otologicals

S02A - Antiinfectives

S02AA - Antiinfectives

S02AA03 - Boric acid


5.4 Absorption, Distribution and Excretion

Absorption

Boric acid is well absorbed from the gastrointestinal tract, open wounds, and serous cavities but displays limited absorption in intact skin. Following intraperitoneal injection in mice, the peak concentration was reached in about 1.0-1.5 hr in the brain whereas the value was 0.5 hr in other tissues.


Route of Elimination

Regardless the route of administration, boric acid predominantly undergoes rapid renal excretion of >90% of total administered dose as unchanged form. Small amounts are also excreted into sweat, saliva, and feces. Following administration as ointment, urinary excretion of boric acid accounted for only 1% of the administered dose.


Volume of Distribution

Volume of distribution ranges from 0.17 to 0.5 L/kg in humans, where large amounts of boric acid are localized in brain, liver, and kidney.


Clearance

A case report of acute boric acid poisoning following oral ingestion of 21 g of boric acid presents the total body clearance of 0.99 L/h before hemodialysis.


Boric acid is readily absorbed from GI tract, serous cavities, and abraded or inflamed skin. It does not penetrate intact skin. Approximately 50% of given dose is excreted within 24 hr. During chronic administration, plateau in urinary excretion is reached only after 2 wk. ... Large amounts of boric acid are localized in brain, liver, and kidney. ... Intracytoplasmic inclusions in pancreas /have been noted/ in fatal cases. /Boric acid/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 995


In animals, boric acid has been shown to be readily absorbed from the GI tract. Among the species studied were rats, rabbits, sheep, and cattle.

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V3 p.535


... Boric acid (5%) was applied topically to 10-15% of the body surface of rabbits with an occlusive dressing for 1.5 hr per day for 4 consecutive days. Minimal amounts of boric acid were absorbed across intact skin and slightly abraded skin of rabbits as measured by excretion of B in urine. Absorption was greater in rabbits with more seriously damaged skin.

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V3 p.535


In rats given boric acid in an ointment, urinary excretion accounted for only 1% of the administered dose. However, boric acid applied to the skin of rats in an aqueous jelly was absorbed, with 23% of the administered dose appearing in the urine.

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V3 p.535


For more Absorption, Distribution and Excretion (Complete) data for BORIC ACID (24 total), please visit the HSDB record page.


5.5 Metabolism/Metabolites

No metabolic pathways reported.


Metabolism of inorganic borates by biological systems is not feasible owing to the excessive energy (523 kJ/mol) required to break the boron-oxygen bond. Inorganic borates, in low concentrations, convert to boric acid at physiological pH in the aqueous layer overlying mucosal surfaces prior to absorption. This is supported by the evidence in both human and animal studies, where more than 90% of the administered dose of borate is excreted as boric acid. There is evidence in both in vitro and in vivo systems that boric acid has an affinity for cis-hydroxyl groups, and this may be the mechanism that explains the biological effects of boric acid. However, this attachment is known to be reversible and concentration dependent, responding to clearance mechanisms.

WHO; Environmental Health Criteria 204: Boron p.62 (1998). Available from, as of May 12, 2005: https://www.inchem.org/pages/ehc.html


5.6 Biological Half-Life

According to human cases of poisoning, the elimination half-life of boric acid ranges from 13 to 24 hours.


The kinetics of elimination of boron have been evaluated in human volunteers given boric acid via the intravenous and oral routes. The half-life for elimination was the same by either route in these studies and was approximately 21 hr.

WHO; Environmental Health Criteria 204: Boron p.66 (1998). Available from, as of May 12, 2005: https://www.inchem.org/pages/ehc.html


A mean half-life of 13.4 hours (range, 4 to 28 hours) was reported in nine human cases of poisoning /with boric acid/.

Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 1322


In humans, the reported excretion half-life is between 13 and 21 hr.

Krieger, R. (ed.). Handbook of Pesticide Toxicology. Volume 2, 2nd ed. 2001. Academic Press, San Diego, California., p. 1435


The elimination half-life reported for rats is 4.6 hr.

Krieger, R. (ed.). Handbook of Pesticide Toxicology. Volume 2, 2nd ed. 2001. Academic Press, San Diego, California., p. 1435


... Excretion is relatively rapid, occurring over a period of a few to several days, with a half-life of elimination of 24 hr or less.

WHO; Environmental Health Criteria 204: Boron p.66 (1998). Available from, as of May 12, 2005: https://www.inchem.org/pages/ehc.html


5.7 Mechanism of Action

Information regarding the mechanism of action of boric acid in mediating its antibacterial or antifungal actions is limited. Boric acid inhibits biofilm formation and hyphal transformation of _Candida albicans_, which are critical virulence factors. In addition, arrest of fungal growth was observed with the treatment of boric acid.


Boric acid and its derivatives have been shown to promote riboflavinuria in both animals and man. Boric acid complexes with the polyhydroxyl ribitol side chain of riboflavin and greatly increases its water solubility.

PMID:3319474 Pinto JT, Rivlin S; Drug Nutr Interact 5 (3): 143-51 (1987)


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ML","address":"12BOMMASANDRA JIGANI LINK ROADINDL AREAANEKAL TQ BANGALORE","city":"BENGALURU","supplier":"MERCK GROUP","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK","customer":"SIGMA ALDRICH CHEMICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"12.70","actualQuantity":"12.7","unit":"LTR","unitRateFc":"11078.5","totalValueFC":"2785.4","currency":"INR","unitRateINR":"18046.8","date":"09-May-2023","totalValueINR":"229194.74","totalValueInUsd":"2785.4","indian_port":"BANGALORE ICD","hs_no":"29091990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"United States","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"","customerAddress":"12BOMMASANDRA JIGANI LINK ROADINDL AREAANEKAL TQ BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684521000,"product":"BORIC ACID FOR TESTING PURPOSE ONLY","address":"PLOT NO.204 & 237,BOMMASANDRA-JIGAN","city":"BANGALORE","supplier":"HUUE INC","supplierCountry":"UNITED STATES","foreign_port":"SAN FRANCISCO CA","customer":"LAURUS BIO PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"12","unit":"GMS","unitRateFc":"0.1","totalValueFC":"1.2","currency":"USD","unitRateINR":"8.4","date":"20-May-2023","totalValueINR":"100.9","totalValueInUsd":"1.2","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"United States","selfForZScoreResived":"Pharma Grade","supplierPort":"SAN FRANCISCO CA","supplierAddress":"","customerAddress":"PLOT NO.204 & 237,BOMMASANDRA-JIGAN"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731004200,"product":"TETRAFLUOROBORIC ACID DIETHYL ETHER COMPLEX","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"N\/A","supplier":"OAKWOOD PRODUCT INC.","supplierCountry":"UNITED STATES","foreign_port":"ESTILL SPRINGS, TN","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"1.1","totalValueFC":"110.7","currency":"USD","unitRateINR":"93.4","date":"08-Nov-2024","totalValueINR":"9344","totalValueInUsd":"110.7","indian_port":"Biocon-SEZ","hs_no":"29420090","bill_no":"1014584","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"ESTILL SPRINGS, TN","supplierAddress":"N\/A","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"}]
16-Jan-2021
08-Nov-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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ABOUT THIS PAGE

Boric Acid Manufacturers

A Boric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boric Acid, including repackagers and relabelers. The FDA regulates Boric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boric Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Boric Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Boric Acid Suppliers

A Boric Acid supplier is an individual or a company that provides Boric Acid active pharmaceutical ingredient (API) or Boric Acid finished formulations upon request. The Boric Acid suppliers may include Boric Acid API manufacturers, exporters, distributors and traders.

click here to find a list of Boric Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Boric Acid USDMF

A Boric Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Boric Acid active pharmaceutical ingredient (API) in detail. Different forms of Boric Acid DMFs exist exist since differing nations have different regulations, such as Boric Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Boric Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Boric Acid USDMF includes data on Boric Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Boric Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Boric Acid suppliers with USDMF on PharmaCompass.

Boric Acid JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Boric Acid Drug Master File in Japan (Boric Acid JDMF) empowers Boric Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Boric Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Boric Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Boric Acid suppliers with JDMF on PharmaCompass.

Boric Acid CEP

A Boric Acid CEP of the European Pharmacopoeia monograph is often referred to as a Boric Acid Certificate of Suitability (COS). The purpose of a Boric Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Boric Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Boric Acid to their clients by showing that a Boric Acid CEP has been issued for it. The manufacturer submits a Boric Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Boric Acid CEP holder for the record. Additionally, the data presented in the Boric Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Boric Acid DMF.

A Boric Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Boric Acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Boric Acid suppliers with CEP (COS) on PharmaCompass.

Boric Acid WC

A Boric Acid written confirmation (Boric Acid WC) is an official document issued by a regulatory agency to a Boric Acid manufacturer, verifying that the manufacturing facility of a Boric Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Boric Acid APIs or Boric Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Boric Acid WC (written confirmation) as part of the regulatory process.

click here to find a list of Boric Acid suppliers with Written Confirmation (WC) on PharmaCompass.

Boric Acid NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Boric Acid as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Boric Acid API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Boric Acid as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Boric Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Boric Acid NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Boric Acid suppliers with NDC on PharmaCompass.

Boric Acid GMP

Boric Acid Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Boric Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Boric Acid GMP manufacturer or Boric Acid GMP API supplier for your needs.

Boric Acid CoA

A Boric Acid CoA (Certificate of Analysis) is a formal document that attests to Boric Acid's compliance with Boric Acid specifications and serves as a tool for batch-level quality control.

Boric Acid CoA mostly includes findings from lab analyses of a specific batch. For each Boric Acid CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Boric Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Boric Acid EP), Boric Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Boric Acid USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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