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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
Pemetrexed Disodium Impurity 31-40 Pemetrexed Disodium Impurity 31-40
Paclitaxel EP impurity drops Paclitaxel EP impurity drops
Ticagrelor impurity PDD Ticagrelor impurity PDD
octahydro-1H,8H-dipyrazolo[1,2-a:1',2'-e][1,2,5,6]tetrazocine octahydro-1H,8H-dipyrazolo[1,2-a:1',2'-e][1,2,5,6]tetrazocine
Bimatoprost Impurity S Bimatoprost Impurity S
4,4′-DIPHENOQUINONE (DQ) 4,4′-DIPHENOQUINONE (DQ) 494-72-4 C12H8O2
ACETYLSIMVASTATIN ACETYLSIMVASTATIN 145576-25-6 C27H40O6
5-[2-(4'-METHYLBIPHENYL)]TETRAZOLE 5-[2-(4'-METHYLBIPHENYL)]TETRAZOLE 120568-11-8 C14H12N4
L-2-Aminobutanamide L-2-Aminobutanamide 7324-11-0 C4H10N2O
1H-Imidazole-1-carboxylic acid, (1R)-2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-1-[[[(2R)-3-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-2-[(1H-imidazol-1-ylcarbonyl)oxy]propyl][4-(3-oxo-4-morpholinyl)phenyl]amino]methyl]ethyl ester 1H-Imidazole-1-carboxylic acid, (1R)-2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-1-[[[(2R)-3-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-2-[(1H-imidazol-1-ylcarbonyl)oxy]propyl][4-(3-oxo-4-morpholinyl)phenyl]amino]methyl]ethyl ester 2097255-05-3 C40H34N8O10
Elagolix Sodium impurity5 Elagolix Sodium impurity5
Tadalafil Impurity 46 Tadalafil Impurity 46
(trans)-4-((2-amino-3,4-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-3,4-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
(trans)-3-(4-((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl)butane-1,2,4-triol (trans)-3-(4-((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl)butane-1,2,4-triol
Cefdinir CP Impurity B Cefdinir CP Impurity B
Voriconazole Impurity 15 Voriconazole Impurity 15 321589-00-8 C22H19F4N7O
Fluconazole Impurity 2 Fluconazole Impurity 2
Imatinib EP Impurity D Chloride Imatinib EP Impurity D Chloride
S-(+)-O-DESMETHYL VENLAFAXINE S-(+)-O-DESMETHYL VENLAFAXINE 142761-12-4 C16H25NO2
cefdinir cefdinir
ACICLOVIR, Impurity J ACICLOVIR, Impurity J
1H-Inden-1-amine, 2,3-dihydro-N-2-propen-1-yl- 1H-Inden-1-amine, 2,3-dihydro-N-2-propen-1-yl- 91639-43-9 C12H15N
Salbutamol impurity 42 Salbutamol impurity 42 18910-69-5 C14H23NO3
(E)-8-(3,4-dimethoxystyryl) (E)-8-(3,4-dimethoxystyryl)
tert-butyl (3R,5R)-7-((3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanamido)-3,5-dihydroxyheptanoate tert-butyl (3R,5R)-7-((3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanamido)-3,5-dihydroxyheptanoate
(+)-Mediresinol Di-O-β-D-glucopyranoside (+)-Mediresinol Di-O-β-D-glucopyranoside 88142-63-6 C33H44O17
Favipiravir Impurity Favipiravir Impurity
Vildagliptin Dione Impurity Vildagliptin Dione Impurity 1844894-70-7 C17H24N2O3
Adsorption of hydrogen sulfide Adsorption of impurities in water filter material Adsorption of hydrogen sulfide Adsorption of impurities in water filter material
Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate 1440961-11-4 C22H21FN2O6
1H-Pyrrole-3-carboxamide, 5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-N-(2-hydroxyethyl)-2,4-dimethyl- 1H-Pyrrole-3-carboxamide, 5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-N-(2-hydroxyethyl)-2,4-dimethyl- 2170562-55-5 C18H18FN3O3
Apixaban Impurity 70 Apixaban Impurity 70 1998079-14-3 C44H40N8O9
Favipiravir Impurity 14 Favipiravir Impurity 14 356783-49-8 C5HClFN3
Posaconazole Impurity 93 Posaconazole Impurity 93 165115-82-2 C19H19F2IO2
N-Dealkyl Flurazepam (Midazolam impurity) N-Dealkyl Flurazepam (Midazolam impurity)
4-((3-amino-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
AMIKACIN IMPURITY A AMIKACIN IMPURITY A
FUROSEMIDE IMPURITY A FUROSEMIDE IMPURITY A C12H11ClN2O5S
GLICLAZIDE IMPURITY F GLICLAZIDE IMPURITY F
ONDANSETRON IMPURITY D ONDANSETRON IMPURITY D
PERINDOPRIL IMPURITY A PERINDOPRIL IMPURITY A
(E)-Ceftiofur (E)-Ceftiofur 120882-20-4 C19H17N5O7S3
sodium 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)-1-oxidopiperazin-1-yl)ethoxy)acetate sodium 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)-1-oxidopiperazin-1-yl)ethoxy)acetate
Brivaracetam Impurity 25 Brivaracetam Impurity 25 10547-88-3 C7H12O2
(S)-N-((R)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide (S)-N-((R)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide
Peramivir Impurity 19 Peramivir Impurity 19
Diquafosol Impurity 13 Diquafosol Impurity 13 211448-81-6 C18H28N4O29P6
Montelukast Sodium EP Impurity G Montelukast Sodium EP Impurity G 1428448-96-7 C35H37ClNNaO3S
Amifostine related impurities 2 Amifostine related impurities 2 17002-55-0 C8H21N3O
Oxacillin Impurity F Oxacillin Impurity F 5053-35-0 C19H19N3O4S2
Peramivir Impurity 30 Peramivir Impurity 30 2758048-79-0 C20H36N2O6
(E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile 178676-65-8 C13H13NO
3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE 3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE C32H36N2O4S3
Bimatoprost Impurity 15 Bimatoprost Impurity 15
1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester 1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester 116983-17-6 C18H20N2O6
Cabozantinib impurity 37 Cabozantinib impurity 37
4-(1-bromoethyl)-6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine 4-(1-bromoethyl)-6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine
ethyl 6-bromo-4,7-bis((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate ethyl 6-bromo-4,7-bis((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate
2-Benzylidene isobutyryl acetanilide 2-Benzylidene isobutyryl acetanilide 125971-57-5 C19H19NO2
Bisoprolol Impurity 9 Bisoprolol Impurity 9 59383-52-7 C15H25NO3
Empagliflozin Impurity 87 Empagliflozin Impurity 87
Amoxicillin USP Impurity M Amoxicillin USP Impurity M
Aztreonam Impurities 06 Aztreonam Impurities 06 730928-60-6 C26H34N10O16S4
sodium (4-(2-(2-amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate sodium (4-(2-(2-amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate
Lenvatinib Impurity LFZZ-9 Lenvatinib Impurity LFZZ-9 C43H38Cl2N8O8
Rosuvastatin Impurity 118 Rosuvastatin Impurity 118
Rosuvastatin Impurity 117 Rosuvastatin Impurity 117
Cytarabine Impurity 10 Cytarabine Impurity 10 84902-98-7 C4H6N2O3
Ticagrelor Impurity 108 Ticagrelor Impurity 108
4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]- 4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]- 1290121-42-4 C29H35ClN6O4S2
1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?- 1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?- 2410649-54-4 C22H26N6O6
1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 2416241-95-5 C17H18FN3O2S
Dolutegravir Impurity 8 Dolutegravir Impurity 8 2244161-72-4 C20H19F2N3O5
3-((2-((tert-butoxycarbonyl)(methyl)amino)acetoxy)methyl)-2-(((1-chloroethoxy)carbonyl)(methyl)amino)pyridine 1-oxide 3-((2-((tert-butoxycarbonyl)(methyl)amino)acetoxy)methyl)-2-(((1-chloroethoxy)carbonyl)(methyl)amino)pyridine 1-oxide
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)- 2395025-37-1 C17H19N3O8S2
Atorvastatin Impurity 83 Atorvastatin Impurity 83 1807481-00-0 C33H35F2N2NaO5
Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester) Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester) 182069-19-8 C25H34O7
Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)- Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)- 2252417-17-5 C11H22N2O3
1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester 1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester 1640981-16-3 C18H18N2O3
Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester 10367-96-1 C13H17ClN2O4
(2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid (2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl isopropyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl isopropyl sulfate
Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester 2241304-69-6 C15H17Cl2NO3
Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]- Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]- 2227126-13-6 C22H24BNO5
(Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester 1255912-98-1 C14H19N5O8S2
Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)- Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)- 185030-09-5 C13H14O3
1-Piperazinecarboxaldehyde, 4-cyclohexyl- 1-Piperazinecarboxaldehyde, 4-cyclohexyl- 2325305-38-0 C11H20N2O
1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)- 1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)- 2170761-55-2 C11H17NO3
Revefenacin ImpurityABCDEFGHJKL Revefenacin ImpurityABCDEFGHJKL
Peramivir Impurity 57 Peramivir Impurity 57
2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)- 2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)- 1534575-19-3 C7H4BrClN2S2
NA NA
BrivaracetamImpurity ABCDEFGHJKL BrivaracetamImpurity ABCDEFGHJKL
DEHYDRO FELODIPINE-13C4 DEHYDRO FELODIPINE-13C4 96382-71-7 C18H17Cl2NO4
Avatrombopag Impurity 24 Avatrombopag Impurity 24
(S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic acid (S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic acid
Cisatracurium besylate impurity 20 Cisatracurium besylate impurity 20 96946-54-2 C59H77N2O15S+
N-Desmethylondansetron N-Desmethylondansetron 99614-14-9 C17H17N3O
CHEMPACIFIC 59929 CHEMPACIFIC 59929 856240-62-5 C18H24O4
Linagliptin ImpurityABCDEF Linagliptin ImpurityABCDEF
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