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Chemistry

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Also known as: L-serine, 56-45-1, (s)-2-amino-3-hydroxypropanoic acid, (s)-serine, H-ser-oh, Beta-hydroxyalanine
Molecular Formula
C3H7NO3
Molecular Weight
105.09  g/mol
InChI Key
MTCFGRXMJLQNBG-REOHCLBHSA-N
FDA UNII
452VLY9402

Serine
A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from GLYCINE or THREONINE. It is involved in the biosynthesis of PURINES; PYRIMIDINES; and other amino acids.
1 2D Structure

Serine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-amino-3-hydroxypropanoic acid
2.1.2 InChI
InChI=1S/C3H7NO3/c4-2(1-5)3(6)7/h2,5H,1,4H2,(H,6,7)/t2-/m0/s1
2.1.3 InChI Key
MTCFGRXMJLQNBG-REOHCLBHSA-N
2.1.4 Canonical SMILES
C(C(C(=O)O)N)O
2.1.5 Isomeric SMILES
C([C@@H](C(=O)O)N)O
2.2 Other Identifiers
2.2.1 UNII
452VLY9402
2.3 Synonyms
2.3.1 MeSH Synonyms

1. L Serine

2. L-serine

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 105.09 g/mol
Molecular Formula C3H7NO3
XLogP3-3.1
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass105.042593085 g/mol
Monoisotopic Mass105.042593085 g/mol
Topological Polar Surface Area83.6 Ų
Heavy Atom Count7
Formal Charge0
Complexity72.6
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Used as a natural moisturizing agent in some cosmetics and skin care products.


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 Absorption, Distribution and Excretion

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)


5.3 Mechanism of Action

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.


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ROAD","city":"CHENNAI, TAMILNADU -","supplier":"ARCHER (NINGBO) IMP& EXPCOLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TABLETS (INDIA) LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"49.5","totalValueFC":"1249.4","currency":"USD","unitRateINR":"4346","date":"24-Feb-2025","totalValueINR":"108650.94","totalValueInUsd":"1249.4","indian_port":"Madras Sea","hs_no":"29224290","bill_no":"8531906","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.138 ZHONGXING RD. NINGBO (315040) ZHEJIANG CHINA SDNF CN","customerAddress":"NO.179, T.H. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"L- SERINE (BULK DRUGS-AMINO ACIDS INJ.GRADE) (LIST 4SL.NO.52) (IGST.LIST 1SL.NO.174)BULK DRUGS","address":"NO.179, T.H. 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ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743532200,"product":"D-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIALUSE AND NOT FOR MEDICINAL USED-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIAL","address":"NO 9, CATHEDRAL ROAD","city":"TAMIL NADU","supplier":"MITSUI CHEMICALS INC","supplierCountry":"JAPAN","foreign_port":"HAKATA","customer":"CHEMPLAST SANMAR LIMITED","customerCountry":"INDIA","quantity":"36000.00","actualQuantity":"36000","unit":"KGS","unitRateFc":"27.9","totalValueFC":"1025406.7","currency":"USD","unitRateINR":"2438.2","date":"02-Apr-2025","totalValueINR":"87776640","totalValueInUsd":"1025406.7","indian_port":"Madras Sea","hs_no":"29225090","bill_no":"9251082","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HAKATA","supplierAddress":"TOKYO MIDTOWN YAESU,YAESU CENTRAL T OWER,2-2-1 YAESU, CHO-KU TOKYO -104 -28 Japan","customerAddress":"NO 9, CATHEDRAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743705000,"product":"D-SERINE ((R)-2-AMINO-3- HYDROXYPROPANOIC ACID) - INDUSTRIALUSE AND NOT FOR MEDICINAL USED-SERINE ((R)-2-AMINO-3- HYDROXYPROPANOIC ACID) - INDUSTRIAL","address":"NO 9, CATHEDRAL ROAD","city":"TAMIL NADU","supplier":"APELOA HONGKONG LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CHEMPLAST SANMAR LIMITED","customerCountry":"INDIA","quantity":"12000.00","actualQuantity":"12000","unit":"KGS","unitRateFc":"17.5","totalValueFC":"211841.9","currency":"USD","unitRateINR":"1511.2","date":"04-Apr-2025","totalValueINR":"18134040","totalValueInUsd":"211841.9","indian_port":"Madras Sea","hs_no":"29225090","bill_no":"9289242","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"FLAT\/RM 2914 29\/F HO KING COMMERCIA L CENTRE 2-16 FA YUEN STREET MONGKO K KL HONGKONG Hong Kong, , Hong Kon Hong Kong","customerAddress":"NO 9, CATHEDRAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743791400,"product":"L-SERINE L-SERINE","address":"PLOT No 74 B J N PHARMA CITY","city":"Visakhapatnam","supplier":"NANJING GREENWAY LIFESCIENCE CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"LAURUS SYNTHESIS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"107","totalValueFC":"378.9","currency":"USD","unitRateINR":"9266.2","date":"05-Apr-2025","totalValueINR":"32431.7","totalValueInUsd":"378.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9312445","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ROOM 501,BUILDING 9TH,NO.6 JINMA RO AD,MAQUN QIXIA,NANJING,JIANGSU,2100 49 CHINA. China","customerAddress":"PLOT No 74 B J N PHARMA CITY"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743964200,"product":"D-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIALUSE AND NOT FOR MEDICINAL USED-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIAL","address":"NO 9, CATHEDRAL ROAD","city":"TAMIL NADU","supplier":"SAMTON INTEGRATION PTE LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CHEMPLAST SANMAR LIMITED","customerCountry":"INDIA","quantity":"12000.00","actualQuantity":"12000","unit":"KGS","unitRateFc":"16","totalValueFC":"193632","currency":"USD","unitRateINR":"1381.3","date":"07-Apr-2025","totalValueINR":"16575240","totalValueInUsd":"193632","indian_port":"Madras Sea","hs_no":"29225090","bill_no":"9351406","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"11 BEACH ROAD #03-01 CRASCO BUILDIN G SINGAPORE SDNF Singapore","customerAddress":"NO 9, CATHEDRAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744482600,"product":"N-TERT-BUTOXYCARBONYL-L-SERINE METHYL ESTER N-TERT-BUTOXYCARBONYL-L-SERINE METHYL ESTER","address":"FLAT NO 710,7TH FLOOR,,ADITYA TRAD","city":"HYDERABAD,TELANGANA","supplier":"NANJING ZHUODA BIOMEDICAL TECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"ANGENE CHEMICAL PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5000","unit":"GMS","unitRateFc":"0","totalValueFC":"222.8","currency":"USD","unitRateINR":"3.8","date":"13-Apr-2025","totalValueINR":"19069.32","totalValueInUsd":"222.8","indian_port":"Hyderabad Air","hs_no":"29183090","bill_no":"9466363","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"ADD: ROOM 404, BUILDING 4, NO. 21, LIDAO ROAD, TAISHAN STREET, JIANGBEI NEW DISTRICT, NANJING CN","customerAddress":"FLAT NO 710,7TH FLOOR,,ADITYA TRAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"D-SERINE ((R)-2-AMINO-3- HYDROXYPROPANOIC ACID) - INDUSTRIALUSE AND NOT FOR MEDICINAL USED-SERINE ((R)-2-AMINO-3- HYDROXYPROPANOIC ACID) - INDUSTRIAL","address":"NO 9, CATHEDRAL ROAD","city":"TAMIL NADU","supplier":"APELOA HONGKONG LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CHEMPLAST SANMAR LIMITED","customerCountry":"INDIA","quantity":"12000.00","actualQuantity":"12000","unit":"KGS","unitRateFc":"17.5","totalValueFC":"211841.9","currency":"USD","unitRateINR":"1511.2","date":"15-Apr-2025","totalValueINR":"18134040","totalValueInUsd":"211841.9","indian_port":"Madras Sea","hs_no":"29225090","bill_no":"9502662","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"FLAT\/RM 2914 29\/F HO KING COMMERCIA L CENTRE 2-16 FA YUEN STREET MONGKO K KL HONGKONG Hong Kong, , Hong Kon Hong Kong","customerAddress":"NO 9, CATHEDRAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"D-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIALUSE AND NOT FOR MEDICINAL USED-SERINE ((R)-2-AMINO-3-HYDROXYPROPANOIC ACID) - INDUSTRIAL","address":"NO 9, CATHEDRAL ROAD","city":"TAMIL NADU","supplier":"APELOA HONGKONG LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"CHEMPLAST SANMAR LIMITED","customerCountry":"INDIA","quantity":"12000.00","actualQuantity":"12000","unit":"KGS","unitRateFc":"17.5","totalValueFC":"211841.9","currency":"USD","unitRateINR":"1511.2","date":"17-Apr-2025","totalValueINR":"18134040","totalValueInUsd":"211841.9","indian_port":"Madras Sea","hs_no":"29225090","bill_no":"9552665","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"FLAT\/RM 2914 29\/F HO KING COMMERCIA L CENTRE 2-16 FA YUEN STREET MONGKO K KL HONGKONG Hong Kong","customerAddress":"NO 9, CATHEDRAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745260200,"product":"L- SERINE (BULK DRUGS-AMINO ACIDS INJ.GRADE) ( LIST 4SL.NO.52) (IGST.LIST 1SL.NO.174)BULK DRUGS","address":"NO.179, T.H. 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04-Jan-2022
24-Apr-2025
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ABOUT THIS PAGE

Looking for 56-45-1 / Serine API manufacturers, exporters & distributors?

Serine manufacturers, exporters & distributors 1

21

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Serine manufacturer or Serine supplier.

PharmaCompass also assists you with knowing the Serine API Price utilized in the formulation of products. Serine API Price is not always fixed or binding as the Serine Price is obtained through a variety of data sources. The Serine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Serine

Synonyms

L-serine, 56-45-1, (s)-2-amino-3-hydroxypropanoic acid, (s)-serine, H-ser-oh, Beta-hydroxyalanine

Cas Number

56-45-1

Unique Ingredient Identifier (UNII)

452VLY9402

About Serine

A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from GLYCINE or THREONINE. It is involved in the biosynthesis of PURINES; PYRIMIDINES; and other amino acids.

L Serine Manufacturers

A L Serine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L Serine, including repackagers and relabelers. The FDA regulates L Serine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L 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 L Serine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

L Serine Suppliers

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

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

L Serine USDMF

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

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

click here to find a list of L Serine suppliers with USDMF on PharmaCompass.

L Serine 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 L Serine Drug Master File in Japan (L Serine JDMF) empowers L 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 L Serine JDMF during the approval evaluation for pharmaceutical products. At the time of L 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 L Serine suppliers with JDMF on PharmaCompass.

L Serine CEP

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

A L Serine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L 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 L Serine suppliers with CEP (COS) on PharmaCompass.

L Serine 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 L Serine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for L Serine 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 L 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.

Compounded drug products

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

click here to find a list of L Serine suppliers with NDC on PharmaCompass.

L Serine GMP

L 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 L 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 L Serine GMP manufacturer or L Serine GMP API supplier for your needs.

L Serine CoA

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

L Serine CoA mostly includes findings from lab analyses of a specific batch. For each L 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.

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