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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
2-(N,N-DIETHYLAMINO)-4,6-DICHLOROTRIAZINE 2-(N,N-DIETHYLAMINO)-4,6-DICHLOROTRIAZINE 2401-64-1 C5H6Cl2N4
(S)-4-Chloro-1,3-butanediol (S)-4-Chloro-1,3-butanediol 139013-68-6 C4H9ClO2
6-CHLORO-1-METHYLURACIL 6-CHLORO-1-METHYLURACIL 31737-09-4 C5H5ClN2O2
5-(Propylthio)-1H-benzimidazol-2-amine 5-(Propylthio)-1H-benzimidazol-2-amine 80983-36-4 C10H13N3S
Ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate Ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate 179688-26-7 C15H21NO8
Hexyl methanesulfonate Hexyl methanesulfonate 16156-50-6 C7H16O3S
5-CHLOROTHIOPHENE-3-CARBOXYLIC ACID 5-CHLOROTHIOPHENE-3-CARBOXYLIC ACID 36157-42-3 C5H3ClO2S
(S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine (S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine 439858-21-6 C17H19ClN2
2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one 2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one 133330-61-7 C14H9Cl2NO
2-Isopropyl-6-propylphenol (Propofol Impurity O) 2-Isopropyl-6-propylphenol (Propofol Impurity O) 74663-48-2 C12H18O
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
Ethanol, 2-[[2-amino-2-(3-ethoxy-4-methoxyphenyl)ethyl]sulfonyl]- Ethanol, 2-[[2-amino-2-(3-ethoxy-4-methoxyphenyl)ethyl]sulfonyl]- 2733250-84-3 C13H21NO5S
2H-1,4-Benzoxazin-3(4H)-one, 8-(2-chloro-1-hydroxyethyl)-6-(phenylmethoxy)- 2H-1,4-Benzoxazin-3(4H)-one, 8-(2-chloro-1-hydroxyethyl)-6-(phenylmethoxy)- 2383660-53-3 C17H16ClNO4
4-chloro-N-(3-chloro-4-fluorophenyl)-8-nitroquinazolin-7-amine 4-chloro-N-(3-chloro-4-fluorophenyl)-8-nitroquinazolin-7-amine
Isavuconazole Impurity 40 Isavuconazole Impurity 40
(2R,3S,4R,5R,6S)-2-((R)-1,2-dihydroxyethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3S,4R,5R,6S)-2-((R)-1,2-dihydroxyethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)tetrahydro-2H-pyran-3,4,5-triol
2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-, 1,1'-dioxide 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-, 1,1'-dioxide 2724840-93-9 C18H15ClN2O4S
Vitamin K1 Impurity C Vitamin K1 Impurity C
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-((5-methylpyridin-3-yl)methyl)piperidine 1-oxide 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-((5-methylpyridin-3-yl)methyl)piperidine 1-oxide
1,3-Dioxo-2-isoindolineaceticacid 1,3-Dioxo-2-isoindolineaceticacid 6296-53-3 C10H7NO4
1-(4-Bromo-2-(hydroxymethyl)phenyl)-4-(dimethylamino)-1-(4-fluorophenyl)butan-1-olhydrochloride 1-(4-Bromo-2-(hydroxymethyl)phenyl)-4-(dimethylamino)-1-(4-fluorophenyl)butan-1-olhydrochloride 488148-10-3 C19H23BrFNO2
Bisoprolol Impurity 42 Bisoprolol Impurity 42
Peramivir Impurity 31(R) Peramivir Impurity 31(R)
Roxatidine Impurity 10 Roxatidine Impurity 10
2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14-tetraen-1-yl)oxy)naphthalen-1-ol 2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14-tetraen-1-yl)oxy)naphthalen-1-ol
2H-Pyrido[3,4-h]-1,4-benzoxazin-3(4H)-one, 7,8,9,10-tetrahydro-6,10-dihydroxy-8-[2-(4-methoxyphenyl)-1,1-dimethylethyl]- 2H-Pyrido[3,4-h]-1,4-benzoxazin-3(4H)-one, 7,8,9,10-tetrahydro-6,10-dihydroxy-8-[2-(4-methoxyphenyl)-1,1-dimethylethyl]- 2727170-18-3 C22H26N2O5
Spiro[4H-3,1-benzoxazine-4,7'(6'H)-pyrrolo[1,2-a]pyrazine]-1',2,4'(1H)-trione, 6'-(1,3-benzodioxol-5-yl)-2',3',8',8'a-tetrahydro-2'-methyl-, (8'aR)- Spiro[4H-3,1-benzoxazine-4,7'(6'H)-pyrrolo[1,2-a]pyrazine]-1',2,4'(1H)-trione, 6'-(1,3-benzodioxol-5-yl)-2',3',8',8'a-tetrahydro-2'-methyl-, (8'aR)- 2747958-44-5 C22H19N3O6
Vildagliptin Chloroacetyl Nitrile (R)-Isomer Vildagliptin Chloroacetyl Nitrile (R)-Isomer 565452-98-4 C7H9ClN2O
Nirmatrelvir Impurity 5 Nirmatrelvir Impurity 5
Brivaracetam Impurity 119 Brivaracetam Impurity 119
Perospirone Impurity 27 Perospirone Impurity 27
	Paxlovid Impurity 11 Paxlovid Impurity 11
3-(2-(cyclopent-3-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide 3-(2-(cyclopent-3-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
Timolol maleate impurity 02 Timolol maleate impurity 02
Fondaparinux sodium impurity 19 Fondaparinux sodium impurity 19
Avatrombopag Impurity 59 Avatrombopag Impurity 59
	Lasmiditan Impurity 3 Lasmiditan Impurity 3 2941086-99-1
Olaparib Adduct Impurity Olaparib Adduct Impurity
8-chloro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b] pyridine 8-chloro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b] pyridine 2514965-36-5
Febuxostat impurity EOX Febuxostat impurity EOX
2-Methyl-4-hydroxy-2H-1,2-benzisothiazine-3-carboxylic acid ethyl ester-1,1-diox 2-Methyl-4-hydroxy-2H-1,2-benzisothiazine-3-carboxylic acid ethyl ester-1,1-diox 35511-15-0 C11H11NO5S
Avermectin A1a, 25-cyclohexyl-4'-O-de(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-23-hydroxy-5-(hydroxyimino)-, (23S)- (9CI) Avermectin A1a, 25-cyclohexyl-4'-O-de(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-23-hydroxy-5-(hydroxyimino)-, (23S)- (9CI) 165108-08-7 C43H63NO12
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
10-bromocarbamazepine 10-bromocarbamazepine 59690-97-0 C15H11BrN2O
ethyl apovincaminate ethyl apovincaminate 42971-12-0 C22H26N2O2
Osimertinib Impurity 15 Osimertinib Impurity 15 2945220-41-5 C56H66N14O4
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
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
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
1H-Cyclopropa[3,4]cyclopenta[1,2-c]pyrazole-1-acetamide, N-[(1S)-1-[3-[3-[bis(methylsulfonyl)amino]-4-chloro-1-(2,2,2-trifluoroethyl)-1H-indazol-7-yl]-6-[3-methyl-3-(methylsulfonyl)-1-butyn-1-yl]-2-pyridinyl]-2-(3,5-difluorophenyl)ethyl]-5,5-difluoro-3b,4,4a,5-tetrahydro-3-(trifluoromethyl)-, (3bS,4aR)- 1H-Cyclopropa[3,4]cyclopenta[1,2-c]pyrazole-1-acetamide, N-[(1S)-1-[3-[3-[bis(methylsulfonyl)amino]-4-chloro-1-(2,2,2-trifluoroethyl)-1H-indazol-7-yl]-6-[3-methyl-3-(methylsulfonyl)-1-butyn-1-yl]-2-pyridinyl]-2-(3,5-difluorophenyl)ethyl]-5,5-difluoro-3b,4,4a,5-tetrahydro-3-(trifluoromethyl)-, (3bS,4aR)- 2189684-58-8 C40H34ClF10N7O7S3
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(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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