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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
Flomoxef Impurity F Flomoxef Impurity F
Tegoprazan Impurity 15 Tegoprazan Impurity 15
Nirmatrelvir Impurity 8 Nirmatrelvir Impurity 8
Nirmatrelvir Impurity 2 Nirmatrelvir Impurity 2
Roxadustat Impurity 17 Roxadustat Impurity 17
Perospirone Impurity 20 Perospirone Impurity 20 1002359-81-0
Dolutegravir Impurity 19 Dolutegravir Impurity 19
Cephalexin Impurity I Cephalexin Impurity I
Fondaparinux sodium impurity 6 Fondaparinux sodium impurity 6
	Fondaparinux sodium impurity 2 Fondaparinux sodium impurity 2
Oxacillin sodium  Impurity I Oxacillin sodium Impurity I
Mixture of Cefoxitin  Impurity E&F Mixture of Cefoxitin Impurity E&F
Revefenacin Impurity 22 Revefenacin Impurity 22
Lasmiditan Impurity 7 Lasmiditan Impurity 7
Febuxostat impurity BAC Febuxostat impurity BAC
4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 866018-46-4 C16H14Cl2O
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
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
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
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 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
Cephalexin Open-Ring Impurity Cephalexin Open-Ring Impurity
Urapidil Impurity 18 Urapidil Impurity 18
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
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
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
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
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
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
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