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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
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
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
(E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER (E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER 96914-67-9 C9H13NO2
Nicergoline Impurity 7 Nicergoline Impurity 7
N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine 10563-27-6 C7H18N2O2
4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate 2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate
Tirofiban Impurity 79 Tirofiban Impurity 79 158808-85-6 C21H34N2O5S
Brivaracetam Impurity 47 Brivaracetam Impurity 47 2755924-55-9
(Glu3)-Carbetocin (Impurity D) (Glu3)-Carbetocin (Impurity D)
4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine (Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 94213-23-7 C9H7Cl2N5
Perampanel Impurity ABCDEFGHJKL Perampanel Impurity ABCDEFGHJKL
ethyl 3-acetoxy-2-butenoate ethyl 3-acetoxy-2-butenoate 29214-62-8 C8H12O4
2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 68751-57-5 C11H11BrCl2O3
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2511244-96-3 C27H36N2O6
Oseltamivir  Impurity 91 Oseltamivir Impurity 91
Oseltamivir  Impurity 80 Oseltamivir Impurity 80
Oseltamivir  Impurity 72 Oseltamivir Impurity 72
4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 2512203-87-9 C14H16Br2N2O
Linagliptin impurity KH-3 Linagliptin impurity KH-3 2279114-27-9 C30H37N7O6
11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 3044-42-6 C23H28O5
Ampicillin Impurity U Ampicillin Impurity U
Canagliflozin Hydroperoxide Impurity Canagliflozin Hydroperoxide Impurity
(E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid (E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid 40038-46-8 C13H10N2O3
Sitagliptin EP Impurity 6 Sitagliptin EP Impurity 6
Vonoprazan-005 Vonoprazan-005 2514735-09-0 C33H27F3N4
D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester 1469771-46-7 C17H23NO4S2
(1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide (1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide
1-Demethyl Hydroxy Daunomycinone 1-Demethyl Hydroxy Daunomycinone 58199-98-7 C20H16O9
(S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid (S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid 1631053-75-2 C23H38N2O5S
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
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)
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-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 1-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 206050-24-0 C10H8ClF2N3
methyl 1-phenylethanesulfonate methyl 1-phenylethanesulfonate 883835-57-2 C9H12O3S
Doxofylline Impurity 22 Doxofylline Impurity 22
Dapoxetine impurity 61 Dapoxetine impurity 61
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
4-(((2R,3S,4R,5R,6R)-6-(Benzyloxy)-3-((diphenoxyphosphoryl)oxy)-4-(tetradecanoyloxy)-5-((S)-3-(tetradecanoyloxy)tetradecanaMido)tetrahydro-2H-pyran-2-yl)Methoxy)-4-oxobutanoic acid 4-(((2R,3S,4R,5R,6R)-6-(Benzyloxy)-3-((diphenoxyphosphoryl)oxy)-4-(tetradecanoyloxy)-5-((S)-3-(tetradecanoyloxy)tetradecanaMido)tetrahydro-2H-pyran-2-yl)Methoxy)-4-oxobutanoic acid 110611-91-1 C71H110NO15P
2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 29122-69-8 C11H13NO3
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
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
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
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 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)
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