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1. L Serine
2. L-serine
1. L-serine
2. 56-45-1
3. (s)-2-amino-3-hydroxypropanoic Acid
4. (s)-serine
5. H-ser-oh
6. Beta-hydroxyalanine
7. L-ser
8. L-(-)-serine
9. (2s)-2-amino-3-hydroxypropanoic Acid
10. L-serin
11. Serine, L-
12. Serinum [latin]
13. Serina [spanish]
14. Serine (van)
15. L-3-hydroxy-alanine
16. (-)-serine
17. Beta-hydroxy-l-alanine
18. L-2-amino-3-hydroxypropionic Acid
19. Serine [usan:inn]
20. Ser (iupac Abbrev)
21. Alpha-amino-beta-hydroxypropionic Acid
22. 2-amino-3-hydroxypropionic Acid
23. L-3-hydroxy-2-aminopropionic Acid
24. (s)-2-amino-3-hydroxypropionic Acid
25. Hsdb 680
26. (s)-(-)-serine
27. 2-amino-3-hydroxypropanoic Acid, (s)-
28. Propanoic Acid, 2-amino-3-hydroxy-, (s)-
29. Mfcd00064224
30. Brn 1721404
31. Ser
32. Chebi:17115
33. (s)-alpha-amino-beta-hydroxypropionic Acid
34. (2s)-2-amino-3-hydroxy-propanoic Acid
35. 6898-95-9
36. Serine (l-serine)
37. 452vly9402
38. Nsc-118365
39. (s)-2-amino-3-hydroxy-propanoic Acid
40. (s)-(+)-2-amino-3-hydroxypropionic Acid
41. Serinum
42. Serene
43. Serina
44. .beta.-hydroxyalanine
45. B-hydroxy-l-alanine
46. Einecs 200-274-3
47. Nsc 118365
48. Rac-serine
49. Racemic Serine
50. 2-amino-3-hydroxypropanoate
51. Unii-452vly9402
52. 3h-l-serine
53. L-serine;
54. H-ser
55. (s)-a-amino-b-hydroxypropionic Acid
56. Serine (usp)
57. 3-hydroxy-l-alanine
58. L-serine,(s)
59. Tocris-0226
60. Tocris-0227
61. L-serine (jp17)
62. Serine [vandf]
63. Serine [hsdb]
64. Serine [inci]
65. Serine [usan]
66. L-alanine, 3-hydroxy-
67. Serine [inn]
68. Serine [who-dd]
69. Lopac-s-4250
70. Serine [ii]
71. Serine [mi]
72. L-serine [fcc]
73. L-serine [jan]
74. Serine [mart.]
75. (l)-serine
76. Bmse000048
77. Bmse000809
78. Bmse000867
79. Bmse000885
80. Epitope Id:150900
81. Ec 200-274-3
82. Schembl1775
83. L-serine [usp-rs]
84. Gtpl726
85. 4-04-00-03118 (beilstein Handbook Reference)
86. Chembl11298
87. Serine [ep Monograph]
88. L-3-hydroxy-2-aminopropionate
89. Serine [usp Monograph]
90. (s)-a-amino-b-hydroxypropionate
91. (s)-b-amino-3-hydroxypropionate
92. Dtxsid60883230
93. (s)-2-amino-3-hydroxypropanoate
94. Dtxsid301031857
95. Pharmakon1600-01301010
96. Zinc895034
97. L-serine - Cas 56-45-1
98. (s)-2-amino-3-hydroxy-propanoate
99. Act08366
100. Hy-n0650
101. L-2-amino-3-hydroxypropanoic Acid
102. L-serine, Vetec(tm), 98.5%
103. Str02557
104. (s)-beta-amino-3-hydroxypropionate
105. Fmoc-(2-aminomethylphenyl)aceticacid
106. L-2-amino-3-hydroxy-propanoic Acid
107. L-serine, >=99.0% (nt)
108. Bdbm50357212
109. Nsc760115
110. (s)-b-amino-3-hydroxypropionic Acid
111. Akos015854115
112. (s)-alpha-amino-beta-hydroxypropionate
113. Ac-1190
114. Ccg-266038
115. Cs-w020136
116. Db00133
117. Nsc-760115
118. (s)-beta-amino-3-hydroxypropionic Acid
119. L-serine, Tested According To Ph.eur.
120. (2s)-2-amino-3-hydroxypropanoic Acid.
121. Ncgc00015952-01
122. Ncgc00024507-01
123. Ncgc00024507-02
124. Bp-13282
125. L-serine, Bioultra, >=99.5% (nt)
126. Sy002847
127. 2-amino-3-hydroxypropanoic Acid-, (s)-
128. Db-029983
129. Propanoic Acid, 2-amino-3-hydroxy-, (s)
130. Am20100375
131. S0035
132. S9353
133. L-serine, Reagentplus(r), >=99% (hplc)
134. L-serine, Vetec(tm) Reagent Grade, >=99%
135. A20660
136. C00065
137. D00016
138. L-serine, Cell Culture Reagent (h-l-ser-oh)
139. 064s224
140. Q183290
141. Sr-01000597708
142. .alpha.-amino-.beta.-hydroxypropionic Acid-, (s)-
143. Sr-01000597708-1
144. L-serine, Certified Reference Material, Tracecert(r)
145. F1905-7047
146. Serine, European Pharmacopoeia (ep) Reference Standard
147. Z1270387256
148. 3ab40d3a-043a-488f-8361-d1bf309f842c
149. L-serine, United States Pharmacopeia (usp) Reference Standard
150. (s)-2-amino-3-hydroxypropanoicacid;2-amion-3-hydroxypropionicacid
151. L-serine, Pharmaceutical Secondary Standard; Certified Reference Material
152. L-serine, From Non-animal Source, Meets Ep, Usp Testing Specifications, Suitable For Cell Culture, 98.5-101.0%
153. L-serine, Pharmagrade, Ajinomoto, Ep, Usp, Jp, Manufactured Under Appropriate Controls For Use In Pharma Or Biopharmaceutical Production, Suitable For Cell Culture
154. L-serine, Pharmagrade, Ajinomoto, Ep, Usp, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production, Suitable For Cell Culture
Molecular Weight | 105.09 g/mol |
---|---|
Molecular Formula | C3H7NO3 |
XLogP3 | -3.1 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 105.042593085 g/mol |
Monoisotopic Mass | 105.042593085 g/mol |
Topological Polar Surface Area | 83.6 Ų |
Heavy Atom Count | 7 |
Formal Charge | 0 |
Complexity | 72.6 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Used as a natural moisturizing agent in some cosmetics and skin care products.
Serine is classified as a nutritionally non-essential amino acid. Serine is critical for the production of the body's proteins, enzymes and muscle tissue. Serine is needed for the proper metabolism of fats and fatty acids. It also helps in the production of antibodies. Serine is used as a natural moisturizing agent in some cosmetics and skin care products. The main source of essential amino acids is from the diet, non-essential amino acids are normally synthesize by humans and other mammals from common intermediates.
IN PT AGE 2-9 YR, SERINE PRESENT IN ACID MUCOPOLYSACCHARIDES. EXCESSIVE ACCUMULATION & EXCRETION IN URINE OF MUCOPOLYSACCHARIDES MAY BE RELATED TO ABNORMAL BONDING BETWEEN MUCOPOLYSACCHARIDES & PROTEIN.
RENNERT OM, DEKABAN AS; AMINO ACID METAB IN PT WITH HURLER'S SYNDROME; METAB, CLIN EXP; 15(5) 429 (1966)
IN PT AGE 2-9 YR, URINARY SERINE EXCRETION INCR FROM 0.059-0.162 UMOL/24 HR & PLASMA SERINE LEVELS INCR FROM 0.102-0.158 UMOL/ML.
RENNERT OM, DEKABAN AS; AMINO ACID METAB IN PT WITH HURLER'S SYNDROME; METAB, CLIN EXP; 15(5) 429 (1966)
IN PT AGE 2-9 YR, SERINE IS PROBABLY NOT ESTERIFIED THROUGH ITS BETA-HYDROXYL GROUP TO ACID MUCOPOLYSACCHARIDES BUT IS LINKED BY CARBOXYL GROUP.
RENNERT OM, DEKABAN AS; AMINO ACID METAB IN PT WITH HURLER'S SYNDROME; METAB, CLIN EXP; 15(5) 429 (1966)
DETERMINATION OF SERINE LEVELS IN 13 REGIONS OF THE RAT CEREBRAL CORTEX FAILED TO SHOW ANY MARKED DIFFERENCES IN THE AMINO ACID CONTENTS OF CORTEX AREAS OF DIVERSE FUNCTIONS.
ELEKES I ET AL; DRUGS, BIOCHEM METAB, SCI MATER PAP COLLOQ 37 (1981)
L-Serine plays a role in cell growth and development (cellular proliferation). The conversion of L-serine to glycine by serine hydroxymethyltransferase results in the formation of the one-carbon units necessary for the synthesis of the purine bases, adenine and guanine. These bases when linked to the phosphate ester of pentose sugars are essential components of DNA and RNA and the end products of energy producing metabolic pathways, ATP and GTP. In addition, L-serine conversion to glycine via this same enzyme provides the one-carbon units necessary for production of the pyrimidine nucleotide, deoxythymidine monophosphate, also an essential component of DNA.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37552
Submission : 2022-10-13
Status : Active
Type : II
Certificate Number : R1-CEP 2014-366 - Rev 01
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 788
Status : Valid
Registration Number : 227MF10148
Registrant's Address : No. 46 Wenjiang Road, Wuming District, Nanning, 530199, Guangxi, P. R. China
Initial Date of Registration : 2015-05-26
Latest Date of Registration : --
NDC Package Code : 16947-8207
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2007-020 - Rev 01
Issue Date : 2014-03-21
Type : Chemical
Substance Number : 788
Status : Valid
Registration Number : 218MF10962
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
NDC Package Code : 16947-8207
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 218MF10658
Registrant's Address : 33, Rue De Verdun Ham France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : --
NDC Package Code : 16947-8207
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-09
Pay. Date : 2021-05-05
DMF Number : 31559
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 1999-159 - Rev 04
Issue Date : 2018-05-17
Type : Chemical
Substance Number : 788
Status : Valid
Registration Number : 226MF10080
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2014-05-02
Latest Date of Registration : --
NDC Package Code : 51495-829
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31568
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 2013-211 - Rev 00
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 788
Status : Valid
NDC Package Code : 51495-829
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6260
Submission : 1986-04-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15668
Submission : 2001-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1806
Submission : 1971-09-20
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-315 - Rev 03
Issue Date : 2020-10-26
Type : Chemical
Substance Number : 788
Status : Valid
Certificate Number : R1-CEP 1999-019 - Rev 03
Issue Date : 2016-11-09
Type : Chemical
Substance Number : 788
Status : Valid
Registration Number : 228MF10226
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2016-12-07
Latest Date of Registration : --
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : Canada
Brand Name : 20% PROSOL
Dosage Form : LIQUID
Dosage Strength : 1.02G/100ML
Packaging : 500/1000/2000ML
Approval Date :
Application Number : 2141450
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : TRAVASOL
Dosage Form : SOLUTION
Dosage Strength : 500MG/100ML
Packaging : 3000
Approval Date :
Application Number : 872296
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : CLINIMIX E
Dosage Form : SOLUTION
Dosage Strength : 250MG/100ML
Packaging : 2000ML
Approval Date :
Application Number : 2142384
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : CLINIMIX E
Dosage Form : SOLUTION
Dosage Strength : 400MG/100ML
Packaging :
Approval Date :
Application Number : 2498413
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : CLINIMIX E
Dosage Form : SOLUTION
Dosage Strength : 400MG/100ML
Packaging :
Approval Date :
Application Number : 2498421
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : CLINIMIX
Dosage Form : SOLUTION
Dosage Strength : 400MG/100ML
Packaging :
Approval Date :
Application Number : 2498456
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : OLIMEL 5.7%
Dosage Form : EMULSION
Dosage Strength : 2.25G/L
Packaging : 1000/1500/2000/2500ML
Approval Date :
Application Number : 2352540
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : OLIMEL 7.6% E
Dosage Form : EMULSION
Dosage Strength : 3G/L
Packaging : 650/1000/1500/2000ML
Approval Date :
Application Number : 2477955
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SMOFKABIVEN EXTRA NITROGEN
Dosage Form : EMULSION
Dosage Strength : 0.43G/100ML
Packaging :
Approval Date :
Application Number : 2501813
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SMOFKABIVEN
Dosage Form : EMULSION
Dosage Strength : 0.33G/100ML
Packaging : 986/1477/1970/2463ML
Approval Date :
Application Number : 2440695
Regulatory Info :
Registration Country : Canada
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Serine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serine, including repackagers and relabelers. The FDA regulates Serine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serine 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 Serine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Serine supplier is an individual or a company that provides Serine active pharmaceutical ingredient (API) or Serine finished formulations upon request. The Serine suppliers may include Serine API manufacturers, exporters, distributors and traders.
click here to find a list of Serine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Serine DMF (Drug Master File) is a document detailing the whole manufacturing process of Serine active pharmaceutical ingredient (API) in detail. Different forms of Serine DMFs exist exist since differing nations have different regulations, such as Serine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Serine DMF submitted to regulatory agencies in the US is known as a USDMF. Serine USDMF includes data on Serine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Serine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Serine suppliers with USDMF on PharmaCompass.
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 Serine Drug Master File in Japan (Serine JDMF) empowers Serine 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 Serine JDMF during the approval evaluation for pharmaceutical products. At the time of Serine 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 Serine suppliers with JDMF on PharmaCompass.
A Serine CEP of the European Pharmacopoeia monograph is often referred to as a Serine Certificate of Suitability (COS). The purpose of a Serine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Serine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Serine to their clients by showing that a Serine CEP has been issued for it. The manufacturer submits a Serine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Serine CEP holder for the record. Additionally, the data presented in the Serine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Serine DMF.
A Serine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Serine 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 Serine suppliers with CEP (COS) on PharmaCompass.
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 Serine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Serine API and other APIs are published in this directory by the FDA.
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 Serine 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.
The NDC directory also contains data on finished compounded human drug products that contain Serine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Serine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Serine suppliers with NDC on PharmaCompass.
Serine 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 Serine 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 Serine GMP manufacturer or Serine GMP API supplier for your needs.
A Serine CoA (Certificate of Analysis) is a formal document that attests to Serine's compliance with Serine specifications and serves as a tool for batch-level quality control.
Serine CoA mostly includes findings from lab analyses of a specific batch. For each Serine 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.
Serine may be tested according to a variety of international standards, such as European Pharmacopoeia (Serine EP), Serine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Serine USP).
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