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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
9-cis Acitretin 9-cis Acitretin 419534-31-9 C21H26O3
N-Desmethylvinblastine N-Desmethylvinblastine 18172-50-4 C45H56N4O9
Rabeprazole Sulfone Rabeprazole Sulfone 117976-47-3 C18H21N3O4S
6-BROMO-3 H-ISOBENZOFURAN-1-ONE 6-BROMO-3 H-ISOBENZOFURAN-1-ONE 19477-73-7 C8H5BrO2
dimethyl 2,6-dimethyl-4-(4-nitrophenyl)-1,4-dihydropyridine-3,5-dicarb oxylate dimethyl 2,6-dimethyl-4-(4-nitrophenyl)-1,4-dihydropyridine-3,5-dicarb oxylate 21829-09-4 C17H18N2O6
TOPOTECANACETATE TOPOTECANACETATE 123948-88-9 C25H27N3O7
BIS(2,6-DIPHENYLPHENOXY)NIOBIUM(V) CHLOR BIS(2,6-DIPHENYLPHENOXY)NIOBIUM(V) CHLOR 699012-35-6 C42H32Cl3NbO2
Brivaracetam Impurity 62 Brivaracetam Impurity 62
Lumateperone Impurity 4 Lumateperone Impurity 4
SugammadexImpurity021 SugammadexImpurity021
Pabocillin Impurity 28 Pabocillin Impurity 28
Cefmetazole Sodium Impurity C Cefmetazole Sodium Impurity C
Ceftriaxone Sodium Oxide Impurity Ceftriaxone Sodium Oxide Impurity
2-[4-(Azidomethyl)phenyl]benzamide 2-[4-(Azidomethyl)phenyl]benzamide
1H-Benzimidazole-7-carboxylic acid, 1-[[2'-[4,5-dihydro-4-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl]-5-oxo-1,2,4-oxadiazol-3-yl][1,1'-biphenyl]-4-yl]methyl]-2-ethoxy- 1H-Benzimidazole-7-carboxylic acid, 1-[[2'-[4,5-dihydro-4-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl]-5-oxo-1,2,4-oxadiazol-3-yl][1,1'-biphenyl]-4-yl]methyl]-2-ethoxy- 1985638-55-8 C30H24N4O8
2H-1,4-Benzoxazin-3(4H)-one, 8-[(1R)-2-bromo-1-hydroxyethyl]-6-(phenylmethoxy)- 2H-1,4-Benzoxazin-3(4H)-one, 8-[(1R)-2-bromo-1-hydroxyethyl]-6-(phenylmethoxy)- 2248125-51-9 C17H16BrNO4
Morpholine, 4-[4-(1,1-dimethylethoxy)-1,2,5-thiadiazol-3-yl]- Morpholine, 4-[4-(1,1-dimethylethoxy)-1,2,5-thiadiazol-3-yl]- 158636-99-8 C10H17N3O2S
Pemetrexed disodium Impurity 30 Pemetrexed disodium Impurity 30
ISOPROPYLAMINE HYDROCHLORIDE ISOPROPYLAMINE HYDROCHLORIDE 15572-56-2 C3H10ClN
Bimatoprost Impurity 17 Bimatoprost Impurity 17
Bumetanide Impurity 10 Bumetanide Impurity 10
Cefoxitin EP Impurity E (R-methoxy cefoxitin) Cefoxitin EP Impurity E (R-methoxy cefoxitin)
4(1H)-Pyrimidinone, 5-amino-6-chloro-2-(propylthio)- 4(1H)-Pyrimidinone, 5-amino-6-chloro-2-(propylthio)- 2512210-21-6 C7H10ClN3OS
Carbamic acid, N-[(1S)-1-methyl-2-oxo-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester Carbamic acid, N-[(1S)-1-methyl-2-oxo-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester 2151127-61-4 C24H23NO4
1-(chloromethyl)-4-(dichloromethyl)benzene 1-(chloromethyl)-4-(dichloromethyl)benzene 7398-44-9 C8H7Cl3
4,4'-(propane-1,3-diyl)bismorpholine 4,4'-(propane-1,3-diyl)bismorpholine 48152-09-6 C11H22N2O2
decyl D-glucoside decyl D-glucoside 54549-25-6 C16H32O6
3-(((2R,3S)-2-((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(3-fluorophenyl)morpholino)methyl)-1H-1,2,4-triazol-5(4H)-one 3-(((2R,3S)-2-((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(3-fluorophenyl)morpholino)methyl)-1H-1,2,4-triazol-5(4H)-one
(S)-4,6,7,11-tetrahydroxy-9-(2-hydroxyacetyl)-7,8-dihydrotetracene-5,12-dione (S)-4,6,7,11-tetrahydroxy-9-(2-hydroxyacetyl)-7,8-dihydrotetracene-5,12-dione
Ruxolitinib ImpurityABCDEFGHJKL Ruxolitinib ImpurityABCDEFGHJKL
Avatrombopag Impurity 76 Avatrombopag Impurity 76
Rosuvastatin Impurity 153 Rosuvastatin Impurity 153
Rosuvastatin Impurity 138 Rosuvastatin Impurity 138
Rosuvastatin Impurity 127 Rosuvastatin Impurity 127
Oxacillin sodium EP impurity J Oxacillin sodium EP impurity J
Piperacillin Sodium EP Impurity P Piperacillin Sodium EP Impurity P
(S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide (S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity B(USP) Ertapenem Impurity B(USP)
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2458312-06-4 C27H30N2O6
15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA 15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA 41639-71-8 C23H32O5
(5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one (5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
RICE BRAN OIL RICE BRAN OIL 68553-81-1
3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]- 2402776-83-2 C16H17N7O2S
Iohexol ImpuritiesE Iohexol ImpuritiesE
TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE 404958-08-3 C10H17ClO4
2-(3-(4-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
	Bumetanide Photodegradable Impurity 16 Bumetanide Photodegradable Impurity 16
Bisoprolol Impurity 47 Bisoprolol Impurity 47
Gadobutrol Impurity 11(Ammonium salt) Gadobutrol Impurity 11(Ammonium salt)
Flomoxef Impurity F Flomoxef Impurity F
Tegoprazan Impurity 15 Tegoprazan Impurity 15
Nirmatrelvir Impurity 8 Nirmatrelvir Impurity 8
Nirmatrelvir Impurity 2 Nirmatrelvir Impurity 2
1-benzyl-4-phenylpiperidin-4-ol 1-benzyl-4-phenylpiperidin-4-ol 63843-83-4 C18H21NO
[(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride 5261-99-4 C7H18ClN2O2+
(S,R)-Palonosetron N-Oxide (S,R)-Palonosetron N-Oxide C19H24N2O2
17,21-dihydroxy-16beta-methylpregna-1,4,9(11)-triene-3,20-dione 17,21-dihydroxy-16beta-methylpregna-1,4,9(11)-triene-3,20-dione 13504-15-9 C22H28O4
Sulfamide, N-[6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-5-phenyl-4-pyrimidinyl]-N'-propyl- Sulfamide, N-[6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-5-phenyl-4-pyrimidinyl]-N'-propyl- 2300968-87-8 C19H21BrN6O4S
Benzeneacetonitrile, 4-(4-chloro-1-oxobutyl)-α,α-dimethyl- Benzeneacetonitrile, 4-(4-chloro-1-oxobutyl)-α,α-dimethyl- 169032-17-1 C14H16ClNO
Oseltamivir Impurity 103 Oseltamivir Impurity 103
Oseltamivir Impurity 101 Oseltamivir Impurity 101
Oseltamivir  Impurity 90 Oseltamivir Impurity 90
Oseltamivir  Impurity 79 Oseltamivir Impurity 79
Oseltamivir  Impurity 73 Oseltamivir Impurity 73
Oseltamivir  Impurity 69 Oseltamivir Impurity 69
10-methoxy-6-methylergoline-8beta-methanol 10-methoxy-6-methylergoline-8beta-methanol 35121-60-9 C17H22N2O2
Azilsartan medoxomil impurity261 Azilsartan medoxomil impurity261 2514957-39-0 C16H16FN3O4
Propanoic acid, 2,2-dimethyl-, 4-[[[2-[[(2-methoxy-2-oxoethyl)amino]carbonyl]phenyl]amino]sulfonyl]phenyl ester Propanoic acid, 2,2-dimethyl-, 4-[[[2-[[(2-methoxy-2-oxoethyl)amino]carbonyl]phenyl]amino]sulfonyl]phenyl ester 127373-95-9 C21H24N2O7S
Fulvestrant Impurity 1 Fulvestrant Impurity 1
CefazolinH020-02-I-02 CefazolinH020-02-I-02
(E)-3-[cyano(2,3-dichlorophenyl)methylene]carbazamidine (E)-3-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 94213-24-8 C9H7Cl2N5
5-Pyrimidinecarboxylic acid, 4-amino-6-[1-[(1R)-2-cyano-1-cyclopentylethyl]-1H-pyrazol-4-yl]- 5-Pyrimidinecarboxylic acid, 4-amino-6-[1-[(1R)-2-cyano-1-cyclopentylethyl]-1H-pyrazol-4-yl]- 2606144-44-7 C16H18N6O2
3-Quinolinecarboxylic acid, 7-[(4aS,7aS)-1-acetyloctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-4-oxo- 3-Quinolinecarboxylic acid, 7-[(4aS,7aS)-1-acetyloctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-4-oxo- 1395471-26-7 C23H26FN3O5
(1S,5R)-9-(4-fluorophenyl)-11-isopropyl-10-phenyl-1,2,6,7-tetrahydro-3H,5H-1,5-methanopyrrolo[1,2-e][1,5]oxazonin-3-one (1S,5R)-9-(4-fluorophenyl)-11-isopropyl-10-phenyl-1,2,6,7-tetrahydro-3H,5H-1,5-methanopyrrolo[1,2-e][1,5]oxazonin-3-one
N-[3-acetyl-4-(oxiranylmethoxy)phenyl]butyramide N-[3-acetyl-4-(oxiranylmethoxy)phenyl]butyramide 28197-66-2 C15H19NO4
8-isopropyl-8-azabicyclo[3.2.1]octan-3-one 8-isopropyl-8-azabicyclo[3.2.1]octan-3-one 3423-28-7 C10H17NO
Sitagliptin EP Impurity 4 Sitagliptin EP Impurity 4
1-[3,5-bis(phenylmethoxy)phenyl]-2-bromoethan-1-one 1-[3,5-bis(phenylmethoxy)phenyl]-2-bromoethan-1-one 28924-18-7 C22H19BrO3
Benzenesulfonic acid, 4-[2-(2-chloro-4-hydroxyphenyl)hydrazinyl]- Benzenesulfonic acid, 4-[2-(2-chloro-4-hydroxyphenyl)hydrazinyl]- 2174956-62-6 C12H11ClN2O4S
Anastrozole Impurity 13 Anastrozole Impurity 13
4,4',6-trioxo-4,4',5,6,7,7'-hexahydro-1H,1'H-[5,6'-bipyrrolo[2,3-d]pyrimidine]-5,5'-diyl)bis(ethane-2,1-diyl))bis(benzoyl))bis(azanediyl))dipentanedioic acid 4,4',6-trioxo-4,4',5,6,7,7'-hexahydro-1H,1'H-[5,6'-bipyrrolo[2,3-d]pyrimidine]-5,5'-diyl)bis(ethane-2,1-diyl))bis(benzoyl))bis(azanediyl))dipentanedioic acid
Cefotiam impurity 07 Cefotiam impurity 07
benzo-1,3-dioxol-5-ol acetate benzo-1,3-dioxol-5-ol acetate 326-58-9 C9H8O4
2-((4R,6S)-6-(chloromethyl)-2,2-dimethyl- 1,3-dioxan-4-yl)acetic acid 2-((4R,6S)-6-(chloromethyl)-2,2-dimethyl- 1,3-dioxan-4-yl)acetic acid 775571-58-9 C9H15ClO4
Ruxolitinib Impurity 1 Ruxolitinib Impurity 1 3027185-21-0 C25H29N7
Cefradine Impurity L Cefradine Impurity L
(8beta)-10methoxy-6-dimethylergoline-8-methanol-5-bromo-3-pyridinecarboxylate(ester) (8beta)-10methoxy-6-dimethylergoline-8-methanol-5-bromo-3-pyridinecarboxylate(ester) 35264-46-1 C23H24BrN3O3
Cephalexin Open-Ring Impurity Cephalexin Open-Ring Impurity
Urapidil Impurity 18 Urapidil Impurity 18
Flomoxef Impurity IV Flomoxef Impurity IV
Pitavastatin Impurity 54 Complete Set Pitavastatin Impurity 54 Complete Set
Cetrorelix Impurity 15 Cetrorelix Impurity 15
Brivaracetam Impurity 46 Brivaracetam Impurity 46
Atracurium Impurity H Complete Set Atracurium Impurity H Complete Set
Peramivir Intermediate Impurity 38 Peramivir Intermediate Impurity 38
Peramivir Guanidine Acetyl Positional Heterogeneous Impurities Peramivir Guanidine Acetyl Positional Heterogeneous Impurities
Ticagrelor impurity P drops Ticagrelor impurity P drops
3-[4-(2-isopropoxyethoxymethyl)phenoxy]-2-(isopropylamino)propan-1-ol 3-[4-(2-isopropoxyethoxymethyl)phenoxy]-2-(isopropylamino)propan-1-ol
Pemetrexed Disodium Impurity 31-40 Pemetrexed Disodium Impurity 31-40
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