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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
Montelukast Cyclopropaneacetonitrile Montelukast Cyclopropaneacetonitrile 866923-62-8 C35H35ClN2OS
(3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate (3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 461432-24-6 C22H27ClO7
Ezetimibe Impurity Ezetimibe Impurity 1510820-22-0 C24H23F2NO2
10,13-bissidechainpaclitaxel 10,13-bissidechainpaclitaxel
Istradefylline Impurity A Istradefylline Impurity A
(3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride (3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride C14H24Cl2N2
2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 142384-07-4 C14H12N4O3S
Valsartan Desvaleryl Impurity Valsartan Desvaleryl Impurity 676129-92-3 C19H21N5O2
Istradefylline iMpurity Istradefylline iMpurity
(E)-Olopatadine Hydrochloride (E)-Olopatadine Hydrochloride 949141-22-4 C21H24ClNO3
(3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-92-2 C15H26O7S
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
Lexithromycin Lexithromycin 53066-26-5 C38H70N2O13
Imimidistine impurity B Imimidistine impurity B
methylprednisolone 17-hemisuccinate methylprednisolone 17-hemisuccinate 77074-42-1 C26H34O8
8-hydroxymethylriboflavin 8-hydroxymethylriboflavin 52134-62-0 C17H20N4O7
RS 42358-197 RS 42358-197 135729-55-4 C19H23ClN2O
4-Desacetyl Vincristine 4-Desacetyl Vincristine 3704-01-6 C44H54N4O9
	Relugolix Impurity 91 Relugolix Impurity 91
D,L N-Desmethylvenlafaxine D,L N-Desmethylvenlafaxine 149289-30-5 C16H25NO2
PIVALOYLOXYMETHYL 6-AMINOPENICILANATE PIVALOYLOXYMETHYL 6-AMINOPENICILANATE 25031-08-7 C14H22N2O5S
(Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid (Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid
(9S)-9-Amino-9-deoxoerythromycin (9S)-9-Amino-9-deoxoerythromycin 26116-56-3 C37H70N2O12
Oseltamivir Impurity 124 Oseltamivir Impurity 124
Oseltamivir Impurity 114 Oseltamivir Impurity 114
Avatrombopag Impurity 69 Avatrombopag Impurity 69
NSC525120 NSC525120 10221-08-6 C8H7Cl3
3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 6305-56-2 C8H13N3O
TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL 46727-91-7 C13H20N2O
Citalopram Related Compound F Citalopram Related Compound F
(1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene (1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene 2229745-37-1 C40H74O2Si2
(+)-Tamsulosin (+)-Tamsulosin 106138-88-9 C20H28N2O5S
2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 96166-39-1 C7H12N2O3
1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 300543-31-1 C12H14N2O
apiopaeonoside apiopaeonoside 100291-86-9 C20H28O12
(2-PHENOXY)METHYLSULFONYLANILINE (2-PHENOXY)METHYLSULFONYLANILINE 51765-51-6 C13H13NO3S
(S)-Cilastatin EP Impurity G (S)-Cilastatin EP Impurity G
4-methoxy-2,3,5-trimethylpyridine 4-methoxy-2,3,5-trimethylpyridine 109371-19-9 C9H13NO
acetylthiamine acetylthiamine 3419-28-1
deacetylcephalosporin C deacetylcephalosporin C 1476-46-6 C14H19N3O7S
N-nitroso-N-methylcyclohexylamine N-nitroso-N-methylcyclohexylamine 5432-28-0 C7H14N2O
ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE 122397-96-0 C15H20O8
4-(2-Cyanophenyl)benzyl alcohol 4-(2-Cyanophenyl)benzyl alcohol 154709-19-0 C14H11NO
1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 117976-94-0 C17H19N3O3S
2',3'-O-isopropylidene cytidine 2',3'-O-isopropylidene cytidine 362-42-5 C12H17N3O5
4,4''-Dimethoxyazoxybenzene 4,4''-Dimethoxyazoxybenzene 501-58-6 C14H14N2O2
3,5-Dibenzyloxy terbutalline 3,5-Dibenzyloxy terbutalline 28924-25-6 C26H31NO3
1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 87233-54-3 C11H13ClN2O
LEYBOLD VACUUM PUMP OIL LEYBOLD VACUUM PUMP OIL 64742-65-0
2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 201166-22-5 C12H16O2
C-Desmethyl Metoprolol C-Desmethyl Metoprolol 109632-08-8 C14H23NO3
(Z)-4-HYDROXYTAMOXIFEN (Z)-4-HYDROXYTAMOXIFEN 65213-48-1 C26H29NO2
10-Methoxyiminostilbene-5-carbonylchloride 10-Methoxyiminostilbene-5-carbonylchloride 28721-08-6 C16H12ClNO2
Afatinib Impurity OLQ Afatinib Impurity OLQ
Afatinib Impurity OLQ Afatinib Impurity OLQ
Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) 119302-22-6 C31H50N2O5
Landiolol impurity W Landiolol impurity W
Metoprolol IMpurity T Metoprolol IMpurity T C15H25NO3
Teneligliptin Impurity 11 Teneligliptin Impurity 11 2131105-24-1 C25H35N5O4
Teneligliptin Impurity 16 Teneligliptin Impurity 16
IMP-EP-M IMP-EP-M 1193104-80-1 C60H79N2O15S+
Hyoscine Butylbromide EP Impurity H Hyoscine Butylbromide EP Impurity H
2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2165770-84-1 C10H19NO4
Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- 1252016-49-1 C27H46N2O3
(S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine (S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine C30H33NO2
ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE 66338-95-2 C6H8ClNO4
2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate 2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate C27H39NO3
Dexamethasone Impurity EP Impurity C Dexamethasone Impurity EP Impurity C
Palbociclib impurity LAAP Palbociclib impurity LAAP
(R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide (R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide C15H30N4O3
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32 1528636-07-8 C22H27ClO7
1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) 1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) C28H54N8O2
N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)- N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)-
Droxidopa Impurity 6 Droxidopa Impurity 6 90044-46-5 C16H15NO4
Osimertinib Impurity 2 DiHCl Osimertinib Impurity 2 DiHCl
Dofetilide Impurity B Dofetilide Impurity B
Sugammadex Monohydroxy Impurity Sugammadex Monohydroxy Impurity
Cyclic Macitentan quarternary salt Impurity Cyclic Macitentan quarternary salt Impurity
Lacosamide Impurity – K Lacosamide Impurity – K
Cefdinir CP Impurity I&J&K&L Cefdinir CP Impurity I&J&K&L
Dapoxetine Impurity 41 Dapoxetine Impurity 41
Doxofylline Impurity 16 Doxofylline Impurity 16
Olopatadine Impurity 5 Olopatadine Impurity 5 55690-18-1 C17H16O5
Taladafil Impurity 38 Taladafil Impurity 38
Salbutamol impurity 41 Salbutamol impurity 41
Gadobutrol Impurity 20 Gadobutrol Impurity 20
Dapagliflozin Impurity 48 Dapagliflozin Impurity 48 2069934-29-6 C15H14Cl2O
Cilostazol Impurity I Cilostazol Impurity I
Lanthanum test solution(ChP) Lanthanum test solution(ChP)
Pramipexole DBTA Impurity Pramipexole DBTA Impurity 1821389-09-6 C7H8N2S
Amoxicillin Oxidized Impurities Amoxicillin Oxidized Impurities
Amoxicillin Oxidized Impurities Amoxicillin Oxidized Impurities
ZIDOVUDINE IMPURITY B ZIDOVUDINE IMPURITY B
24Dichloro-5methoxyacetanilide 24Dichloro-5methoxyacetanilide 65182-98-1 C9H9Cl2NO2
4,4,4-trifluoro-1-(2-methylphenyl)butane-1,3-dione 4,4,4-trifluoro-1-(2-methylphenyl)butane-1,3-dione 163266-02-2 C11H9F3O2
5-chloro-N-(4-nitrophenyl)pentanamide 5-chloro-N-(4-nitrophenyl)pentanamide 1039914-85-6 C11H13ClN2O3
N-(2,6-dimethylphenyl)piperidine-4-carboxamide N-(2,6-dimethylphenyl)piperidine-4-carboxamide 109403-19-2 C14H20N2O
5-{2-[1-(5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol 5-{2-[1-(5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol 73837-24-8 C27H44O3
6-(4-{2-[3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 6-(4-{2-[3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 140710-96-9 C39H72O3Si2
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