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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
4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide 4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide 884330-18-1 C19H22N4O
Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)- Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)- 2469244-33-3 C17H22N4O3
2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl- 2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl- 2486454-64-0 C28H24F5N3O4
3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 2468737-94-0 C24H25Cl2N5O3
1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 313368-81-9 C13H17N3
Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) 40170-12-5 C17H22N2O
Avatrombopag Impurity 22 Avatrombopag Impurity 22
Avatrombopag Impurity 33 Avatrombopag Impurity 33
Cisatracurium besylate impurity 16 Cisatracurium besylate impurity 16
1-ACETYL-2-METHYLBENZIMIDAZOLE 1-ACETYL-2-METHYLBENZIMIDAZOLE 14678-81-0 C10H10N2O
(E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester (E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester 103890-69-3 C14H16O3
1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)- 1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)- 1046533-62-3 C33H33FN2O6
Bimatoprost Impurity 22 Bimatoprost Impurity 22
Bumetanide Impurity 9 Bumetanide Impurity 9
Crisaborole Impurity 14 Crisaborole Impurity 14
Benzonitrile, 4-[(1E)-4-(dimethylamino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxymethyl)- Benzonitrile, 4-[(1E)-4-(dimethylamino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxymethyl)- 1370643-23-4 C20H21FN2O
Latamoxef impurity B Latamoxef impurity B
(9alpha,13alpha,14alpha)-3-methoxymorphinan-17-carbaldehyde (9alpha,13alpha,14alpha)-3-methoxymorphinan-17-carbaldehyde 28973-48-0 C18H23NO2
3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N-(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7-yl)methyl)-N-methylpropan-1-amine oxide 3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N-(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7-yl)methyl)-N-methylpropan-1-amine oxide 2511244-97-4 C27H36N2O6
2,4,6,3',5'-pentamethoxybiphenyl 2,4,6,3',5'-pentamethoxybiphenyl 84212-55-5 C17H20O5
2-benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide 2-benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide 24833-47-4 C17H17NO3
Labetalol EP Impurity I Labetalol EP Impurity I
(Asp4)-Carbetocin (Impurity G) (Asp4)-Carbetocin (Impurity G)
Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-chloro-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-chloro-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- 2443747-63-3 C19H20BrClN6O4S
methyl 3-oxo1,2-benzisothiazole-2(3H)-acetate 1,1-dioxide methyl 3-oxo1,2-benzisothiazole-2(3H)-acetate 1,1-dioxide 6639-62-9 C10H9NO5S
(6R-cis)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-(2-thienylacetamido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (6R-cis)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-(2-thienylacetamido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 54333-94-7 C15H16N2O6S2
5-acetyl-1,3-phenylene bis(dimethylcarbamate) 5-acetyl-1,3-phenylene bis(dimethylcarbamate) 81732-48-1 C14H18N2O5
Oseltamivir  Impurity L Oseltamivir Impurity L
1,4-Naphthalenediol, 2-methyl-, 4-acetate 1,4-Naphthalenediol, 2-methyl-, 4-acetate 110327-29-2 C13H12O3
Oseltamivir Impurity 105 Oseltamivir Impurity 105
Oseltamivir  Impurity 77 Oseltamivir Impurity 77
Imidapril Impurity 2 Imidapril Impurity 2
Betamethasone EP Impurity G Betamethasone EP Impurity G 85700-75-0 C22H30O5
Crisaborole Impurity ABCDEFGHJKL Crisaborole Impurity ABCDEFGHJKL
3-Azetidinecarboxylic acid, 1-[(4-acetyl-2-ethylphenyl)methyl]- 3-Azetidinecarboxylic acid, 1-[(4-acetyl-2-ethylphenyl)methyl]- 2474774-17-7 C15H19NO3
1-chloro-3-(chlorophenylmethyl)benzene 1-chloro-3-(chlorophenylmethyl)benzene 13391-39-4 C13H10Cl2
2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol 2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol
Peramivir Deacetyl Impurity Peramivir Deacetyl Impurity
Empagliflozin Impurity 116 Empagliflozin Impurity 116
(3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid (3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid
Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1) Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1)
Carbazochrome Sodium Sulfonate Impurity 4 Carbazochrome Sodium Sulfonate Impurity 4
Empagliflozin Furanose Impurity Empagliflozin Furanose Impurity
Rosuvastatin Impurity 144 Rosuvastatin Impurity 144
Cetrorelix Impurity 11 Cetrorelix Impurity 11
Cetrorelix Impurity 4 (8-D-Arg) Cetrorelix Impurity 4 (8-D-Arg)
Cetrorelix Impurity 1 (+L-Arg) Cetrorelix Impurity 1 (+L-Arg)
Peramivir Intermediate Impurity 36 Peramivir Intermediate Impurity 36
Peramivir Intermediate Impurity 41 Peramivir Intermediate Impurity 41
Peramivir Impurity 999 Peramivir Impurity 999
Palonosetron impurity 20XH Palonosetron impurity 20XH
Apixaban Impurity 89 Apixaban Impurity 89
Levofloxacin benzopazine impurity Levofloxacin benzopazine impurity
Bumetanide Impurity 14 Bumetanide Impurity 14 1431501-10-8 C21H27NO3
Trans,rel-(1R,4R)-4-{[(2-Aminophenyl)methyl]amino}cyclohexan-1-ol Hydrochloride Trans,rel-(1R,4R)-4-{[(2-Aminophenyl)methyl]amino}cyclohexan-1-ol Hydrochloride
Sugammadex Sodium Impurity 08 Sugammadex Sodium Impurity 08
2-bromo-3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 2-bromo-3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2412953-12-7 C72H112O49S8
4a(2H)-Isoquinolinol, octahydro-4-(4-methoxyphenyl)-2-methyl- 4a(2H)-Isoquinolinol, octahydro-4-(4-methoxyphenyl)-2-methyl- 2568340-30-5 C17H25NO2
3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 2468737-92-8 C25H27Cl2N5O3
Uridine, 4-oxime, 5'-(2-methylpropanoate), (4E)- Uridine, 4-oxime, 5'-(2-methylpropanoate), (4E)- 2492423-30-8 C13H19N3O7
Empagliflozin Furanose Impurity Empagliflozin Furanose Impurity
Tazobactam Impurity XTE Tazobactam Impurity XTE
Isavuconazole Impurity 46 Isavuconazole Impurity 46
5-(1-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-2-hydroxyethyl)-8-hydroxyquinolin-2(1H)-one 5-(1-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-2-hydroxyethyl)-8-hydroxyquinolin-2(1H)-one 2226428-25-5 C24H28N2O3
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2740235-22-5 C13H22N2O5
2-(4-ethylpiperazin-1-yl)-4-(2-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine 2-(4-ethylpiperazin-1-yl)-4-(2-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine C23H30FN3
1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4S)-rel- 1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4S)-rel- 2184053-08-3 C17H17Cl2N
Rosuvastatin Impurity 152 Rosuvastatin Impurity 152
1-[4-(2-AZEPAN-1-YL-ETHOXY)-BENZYL]-5-BENZYLOXY-2-(4-BENZYLOXY-PHENYL)-3-METHYL-1H-INDOLE 1-[4-(2-AZEPAN-1-YL-ETHOXY)-BENZYL]-5-BENZYLOXY-2-(4-BENZYLOXY-PHENYL)-3-METHYL-1H-INDOLE 198480-21-6 C44H46N2O3
6-Heptenoic acid, 7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3S,5R,6E)- 6-Heptenoic acid, 7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3S,5R,6E)- 2273873-66-6 C29H32FNO4
Olodaterol Impurity 26 Olodaterol Impurity 26
2H-3-Benzazepin-2-one, 3-[3-[[(2S)-3-chloro-2-(3,4-dimethoxyphenyl)propyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-[3-[[(2S)-3-chloro-2-(3,4-dimethoxyphenyl)propyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy- 2768438-46-4 C27H37ClN2O5
Ethacridine Impurity 5 Ethacridine Impurity 5 869002-00-6
Olodaterol Impurity 29 Olodaterol Impurity 29
	Elagolix Impurity 40 Elagolix Impurity 40
8-chloro-6-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-7-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 8-chloro-6-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-7-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 2365490-44-2 C13H8ClF2NO4
[3-[[[2-(Diaminomethyleneamino)-4-thiazolyl]methyl]thio]propionyl]sulfamide [3-[[[2-(Diaminomethyleneamino)-4-thiazolyl]methyl]thio]propionyl]sulfamide 106433-44-7 C8H14N6O3S3
3-Formyl-25-desacetyl Rifamycin 3-Formyl-25-desacetyl Rifamycin 16783-97-4 C36H45NO12
4-(3-Methylphenyl)-2H-pyrido[4,3-e]-1,2,4-thiadiazin-3(4H)-one 1,1-Dioxide 4-(3-Methylphenyl)-2H-pyrido[4,3-e]-1,2,4-thiadiazin-3(4H)-one 1,1-Dioxide 72810-61-8 C13H11N3O3S
8-Desacetyl-8-carboxy Daunorubicin Hydrochloride 8-Desacetyl-8-carboxy Daunorubicin Hydrochloride 58199-96-5 C26H27NO11.ClH
D,L N,O-Didesmethylvenlafaxine D,L N,O-Didesmethylvenlafaxine 135308-74-6 C15H23NO2
Desmethyl Erlotinib Acetate Desmethyl Erlotinib Acetate 183320-15-2 C23H23N3O5
Erythromycin E_x000b_Discontinued Erythromycin E_x000b_Discontinued 41451-91-6 C37H65NO14
1,2-Benzenedicarboxylic acid, 3-amino-, 2-ethyl ester 1,2-Benzenedicarboxylic acid, 3-amino-, 2-ethyl ester 1822756-03-5 C10H11NO4
2-(3,4-dihydroxyphenyl)acetaldehyde 2-(3,4-dihydroxyphenyl)acetaldehyde 5707-55-1 C8H8O3
NSC 77154 NSC 77154 4121-39-5 C8H9N5
N-Methyl-N,N-bis(2-pyridylethyl)amine N-Methyl-N,N-bis(2-pyridylethyl)amine 5452-87-9 C15H19N3
Benazepril Related Compound F Benazepril Related Compound F
1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S-trans)- 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S-trans)- 111188-70-6 C22H26N2O4S
1H-Benzimidazole-2-sulfinicacid(9CI) 1H-Benzimidazole-2-sulfinicacid(9CI) 58536-71-3 C7H6N2O2S
1(3H)-Isobenzofuranone,3-methyl-(9CI) 1(3H)-Isobenzofuranone,3-methyl-(9CI) 3453-64-3 C9H8O2
Oprinone Impurity 5 Oprinone Impurity 5
Oprinone Impurity 2 Oprinone Impurity 2
(R)-Cilastatin EP Impurity G (R)-Cilastatin EP Impurity G
3-ETHOXY-4-METHOXYBENZOIC ACID 3-ETHOXY-4-METHOXYBENZOIC ACID 2651-55-0 C10H12O4
4-hydroxyurapidil 4-hydroxyurapidil 88733-12-4 C20H29N5O4
2-chloro-4-nitrophenyl-N-acetylglucosaminide 2-chloro-4-nitrophenyl-N-acetylglucosaminide 103614-82-0 C14H17ClN2O8
Imimidistine impurity D Imimidistine impurity D
desisopropylprocaterol desisopropylprocaterol 63483-95-4 C13H16N2O3
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