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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) 93936-64-2 C23H24FNO4.Na
1-(4-hydroxy-2-methoxyphenyl)ethanone 1-(4-hydroxy-2-methoxyphenyl)ethanone 493-33-4 C9H10O3
Vonoprazan Trimer Impurity Vonoprazan Trimer Impurity
(S)-Citalopram N-Oxide (S)-Citalopram N-Oxide 917482-45-2 C20H21FN2O2
7-Epi-docetaxel (Docetaxel Impurity C) 7-Epi-docetaxel (Docetaxel Impurity C) 153381-68-1 C43H53NO14
Amido Methyl Meloxicam (Meloxicam Impurity) Amido Methyl Meloxicam (Meloxicam Impurity) 892395-41-4 C15H15N3O4S2
Isavuconazole Impurity 35 Isavuconazole Impurity 35
Brivaracetam Impurity 26 HCl Brivaracetam Impurity 26 HCl
Brivaracet amoxidation Impurity 1 Brivaracet amoxidation Impurity 1
Rosuvastatin EP Impurity G Complete Set Rosuvastatin EP Impurity G Complete Set
Bortezomib Impurity G Complete Set Bortezomib Impurity G Complete Set
Peramivir Diacetyl Impurity Peramivir Diacetyl Impurity
Peramivir Chlorisomeric Impurity Peramivir Chlorisomeric Impurity
Canagliflozin impurities 15 drops Canagliflozin impurities 15 drops
Pemetrexed Impurities 41-45 Pemetrexed Impurities 41-45
Pemetrexed Disodium EP Impurity 999 Pemetrexed Disodium EP Impurity 999
Bumetanide Impurity 999 Bumetanide Impurity 999
Canagliflozin Impurity 998 Canagliflozin Impurity 998
3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 57073-55-9 C17H28N4O7S
FEXOFENADINE EP IMPURITY A - HCl FEXOFENADINE EP IMPURITY A - HCl 153439-43-1 C32H38ClNO4
2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 103312-62-5 C14H12ClN3S
Pazufloxacin Pazufloxacin 127046-18-8 C18H19FN2O4
Vinpocetine Vinpocetine 80038-06-8 C22H26N2O2
7-(but-2-yn-1-yl)-8-(3-(hydroxyimino)piperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione 7-(but-2-yn-1-yl)-8-(3-(hydroxyimino)piperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione 1297273-94-9
N,N-dimethyl-1,4,8,11-tetraazacyclotetradecane-1-sulfonamide N,N-dimethyl-1,4,8,11-tetraazacyclotetradecane-1-sulfonamide
Tamsulosin EP Impurity C (Desethoxy Tamsulosin) Tamsulosin EP Impurity C (Desethoxy Tamsulosin)
Itropopa Impurity 17 Itropopa Impurity 17
Cefazolin Epimer Cefazolin Impuirty M (USP), Cefazolin Impurity L (EP) Cefazolin Epimer Cefazolin Impuirty M (USP), Cefazolin Impurity L (EP)
Relugolix Impurity 66 Relugolix Impurity 66 2591260-06-7 C25H24F2N2O6S
methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate
Δ3-7-ACT Δ3-7-ACT
methyl 5-methyl-3'-nitro-3-oxo-1,2,3,6-tetrahydro-[1,1'-biphenyl]-2-carboxylate methyl 5-methyl-3'-nitro-3-oxo-1,2,3,6-tetrahydro-[1,1'-biphenyl]-2-carboxylate 2469735-68-8 C15H15NO5
Pregn-4-ene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)- Pregn-4-ene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)- 3093-36-5 C24H33FO5
2-(3-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2402776-84-3 C23H27N9O4S2
Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)- Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)- 2597901-48-7 C15H27N3O5
3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester 3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester 2711953-58-9 C17H12ClNO4
(2-(2-((tert-butoxycarbonyl)(methyl)amino)-N-methylacetamido)pyridin-3-yl)methyl N-(tert-butoxycarbonyl)-N-methylglycinate (2-(2-((tert-butoxycarbonyl)(methyl)amino)-N-methylacetamido)pyridin-3-yl)methyl N-(tert-butoxycarbonyl)-N-methylglycinate
Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro- Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro- 1870323-25-3 C7H5Cl2NO4S
Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)- Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)- 1431216-61-3 C30H32F6N4O3
1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)- 1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)- 862260-38-6 C36H40FN2NaO5
Avatrombopag Impurity 54 Avatrombopag Impurity 54
Atorvastatin Impurity 45 (Sodium Salt) Atorvastatin Impurity 45 (Sodium Salt)
Tafluprost Impurity 15 Tafluprost Impurity 15
Rosuvastatin Impurity 159 (Sodium salt) Rosuvastatin Impurity 159 (Sodium salt)
Rosuvastatin Impurity 140 Rosuvastatin Impurity 140
Rosuvastatin Impurity 130 Rosuvastatin Impurity 130
Terlipressin Impurity 1 (des-Gly1) Terlipressin Impurity 1 (des-Gly1)
Brivaracetam Impurity 66 Brivaracetam Impurity 66
2-Acetoxymethyl1-3-Methyl-4- 2-Acetoxymethyl1-3-Methyl-4- 112525-75-4 C11H12F3NO3
N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity D(USP) Ertapenem Impurity D(USP)
3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 5409-62-1 C17H20ClNO
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 869884-24-2 C23H26N2O3
Azilsartan Medoxomil Potassium impurity209 Azilsartan Medoxomil Potassium impurity209
TIZOXANIDE GLUCURONIDE, SODIUM SALT TIZOXANIDE GLUCURONIDE, SODIUM SALT 221287-83-8 C16H14N3NaO10S
ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE 28663-68-5 C10H11ClN2O2
Sugammadex sodium Impurity 50 Sugammadex sodium Impurity 50
Cabozantinib impurity 39 Cabozantinib impurity 39
Cabozantinib impurity 53 Cabozantinib impurity 53
1-METHYLBIGUANIDE SULPHATE 1-METHYLBIGUANIDE SULPHATE 1609-00-3 C3H9N5
1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1246815-70-2 C12H18ClNO3
tert-Butyl 4-bromobutanoate tert-Butyl 4-bromobutanoate 110611-91-1 C71H110NO15P
Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) 151003-82-6 C24H34O6
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 762237-66-1 C23H25Cl2N5O2S2
3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 180635-74-9 C10H11F3O
Avatrombopag Impurity 39 Avatrombopag Impurity 39
(1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium (1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium
Nelarabine impurity 01 Nelarabine impurity 01
Pyridine, 2-(diethylboryl)- (9CI) Pyridine, 2-(diethylboryl)- (9CI) 385804-67-1 C9H14BN
Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) 220353-83-3 C9H10FN
3-Pyrazolidinone, 5-cyclopentyl-, (5R)-, (2S,3S)-2,3-dihydroxybutanedioate (1:1) 3-Pyrazolidinone, 5-cyclopentyl-, (5R)-, (2S,3S)-2,3-dihydroxybutanedioate (1:1) 2102675-37-4 C12H20N2O7
1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 693781-59-8 C31H40O2
Bisoprolol Impurity 50 Bisoprolol Impurity 50
Milnacipran Impurity 26 Milnacipran Impurity 26
Olodaterol Impurity 15 Olodaterol Impurity 15
Dobutamine Impurity 15 Dobutamine Impurity 15
2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 1447814-82-5 C18H16Cl2N2S
Pitavastatin Impurity 104 Pitavastatin Impurity 104
Tegoprazan Impurity 8 Tegoprazan Impurity 8
Atomoxetine EP Impurity G DiHCl (Mixture of Diastereomers) Atomoxetine EP Impurity G DiHCl (Mixture of Diastereomers) 2706536-33-4 C27H34N2O2
Nirmatrelvir Impurity 10 Nirmatrelvir Impurity 10
Levosimendan Nitrosogenin Impurities Levosimendan Nitrosogenin Impurities
7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 26973-80-8 C12H13BrN2O6S
Bumetanide Impurity 20 Bumetanide Impurity 20
Rocuronium Bromide Impurity 28 、29 Rocuronium Bromide Impurity 28 、29
Roxadustat Impurity 22 Roxadustat Impurity 22
	Olaparib Impurity 41 Olaparib Impurity 41
Perospirone Impurity 22 Perospirone Impurity 22
Perospirone Impurity 14 Perospirone Impurity 14 87691-94-9 C15H20BrN3S
Dolutegravir Impurity 22 Dolutegravir Impurity 22
Paxlovid Impurity 20 Paxlovid Impurity 20
Related impurities 7 of fluoxetine sodium Related impurities 7 of fluoxetine sodium
Revefenacin Impurity 16 Revefenacin Impurity 16
Fondaparinux sodium impurity 8 Fondaparinux sodium impurity 8 2088176-32-1 C30H50N2O46S7
Fondaparinux sodium impurity 14 Fondaparinux sodium impurity 14
Fondaparinux Sodium Impurity 9 Fondaparinux Sodium Impurity 9
Oxacillin sodium  Impurity D Oxacillin sodium Impurity D
Piracetam      IMPURITY Piracetam IMPURITY
Nilotinib N-Oxide Impurity 4 Nilotinib N-Oxide Impurity 4
sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
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