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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
(3S,4R)-4-(4-Fluorophenyl)piperidine-3-Methanol Hydrochloride (3S,4R)-4-(4-Fluorophenyl)piperidine-3-Methanol Hydrochloride 220548-73-2 C12H17ClFNO
LaMotrigine IMpurity D LaMotrigine IMpurity D 661463-79-2 C9H5Cl2N3O2
(3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol N-Oxide Sulfate (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol N-Oxide Sulfate C24H31NO5S
DeMethylpiperazinyl Desethyl Sildenafil Sulfonyl Chloride DeMethylpiperazinyl Desethyl Sildenafil Sulfonyl Chloride 139756-27-7 C15H15ClN4O4S
Rizatriptan IMpurity B Rizatriptan IMpurity B 1016900-28-9 C13H15ClN5
rac Adrenaline IMpurity D rac Adrenaline IMpurity D 1095714-91-2 C16H19NO3
2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 74926-89-9 C12H16O
Irinotecan IMpurity G Irinotecan IMpurity G 947687-02-7 C35H42N4O6
5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 109882-30-6 C16H23N3O4
5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 325855-74-1 C18H15ClN2O3S
Lafutidine IMpuritiy B Lafutidine IMpuritiy B 174583-84-7 C22H29N3O5S
N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide 905858-63-1 C14H15NO5S2
4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 1357477-99-6 C13H14N2O6S
tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate 763114-04-1 C25H27FN4O4
1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 916975-92-3 C11H8F3N3O2
Edaravone iMpurity P3 Edaravone iMpurity P3 1323485-71-7 C13H16N2O4S
Parent nucleus of cefotiaM hydrochloride Parent nucleus of cefotiaM hydrochloride 372092-19-8 C13H21N7O3S2
Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) 111664-35-8 C22H19NO4
(-)-3-Demethylcolchicine (-)-3-Demethylcolchicine 7336-33-6 C21H23NO6
6-(2,5-dichlorophenyl)-1,3,5-Triazine-2,4(1H,3H)-dione 6-(2,5-dichlorophenyl)-1,3,5-Triazine-2,4(1H,3H)-dione 30222-00-5 C9H5Cl2N3O2
(2'R)-2'-Deoxy-2'-fluoro-2'-Methyl-uridine 3',5'-dibenzoate (2'R)-2'-Deoxy-2'-fluoro-2'-Methyl-uridine 3',5'-dibenzoate 863329-65-1 C24H21FN2O7
Anastrozole iMpurityC Anastrozole iMpurityC
Celecoxib iMpurity-A Celecoxib iMpurity-A
EMtricitabine iMpurity A EMtricitabine iMpurity A
RocuroniuMbroMide iMpurity D RocuroniuMbroMide iMpurity D
Ondansetron Impurity B Ondansetron Impurity B
LeflunoMide EP IMpurity F LeflunoMide EP IMpurity F 1403564-06-6 C12H9F3N2O2
4'-((1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl)biphenyl-2-carboxylic acid 4'-((1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl)biphenyl-2-carboxylic acid
Itraconazole iMpurity D Itraconazole iMpurity D
3-amino-2-chloroacrolein 3-amino-2-chloroacrolein 221615-73-2 C3H4ClNO
3-Amino-4-pyrazolecarbonitrile 3-Amino-4-pyrazolecarbonitrile 16617-46-2 C4H4N4
BenzaMide, 3,4-bis(cyclopropylMethoxy)-N-(3,5-dichloro-4-pyridinyl)- BenzaMide, 3,4-bis(cyclopropylMethoxy)-N-(3,5-dichloro-4-pyridinyl)- 1391052-24-6 C20H20Cl2N2O3
4-ISOBUTYRYLACETOPHENONE 4-ISOBUTYRYLACETOPHENONE 103931-20-0 C12H14O2
ButanaMide, 4-hydroxy-N-(1-Methylethyl)- ButanaMide, 4-hydroxy-N-(1-Methylethyl)- 42042-66-0 C7H15NO2
5H-chroMeno[2,3-b]pyridin-7-ylacetic acid 5H-chroMeno[2,3-b]pyridin-7-ylacetic acid 52549-07-2 C14H11NO3
(S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid (S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid 1151893-81-0 C24H21Cl2N3O7S2
Cilastatin ammonium salt Cilastatin ammonium salt 877674-82-3 C16H29N3O5S
1,4-di(benzo[b]thiophen-4-yl)piperazine 1,4-di(benzo[b]thiophen-4-yl)piperazine 1420987-86-5 C20H18N2S2
(2S,4S)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2S,4S)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-52-4 C23H29NO4
Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoate Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoate 1038924-97-8 C24H27NO4
Cefazoline Impurity A Cefazoline Impurity A
Rifaximin impurity A Rifaximin impurity A
methyl (Z)-3-(((4-(2-(4-(2-((4-((((Z)-6-(methoxymethyl)-2-oxoindolin-3-ylidene)(phenyl)methyl)amino)phenyl)(methyl)amino)-2-oxoethyl)piperazin-1-yl)-N-methylacetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate methyl (Z)-3-(((4-(2-(4-(2-((4-((((Z)-6-(methoxymethyl)-2-oxoindolin-3-ylidene)(phenyl)methyl)amino)phenyl)(methyl)amino)-2-oxoethyl)piperazin-1-yl)-N-methylacetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate 2097505-01-4 C56H54N8O7
Roxithromycin EP Impurity J Roxithromycin EP Impurity J 134834-12-1 C40H73ClN2O14
Venlafaxine D6 Venlafaxine D6 940297-06-3 C17H27NO2
Levosimendan Impurity 3 Levosimendan Impurity 3
Sofosbuvir Impurity29 Sofosbuvir Impurity29
Acarbose Impurity A Acarbose Impurity A
Levosimendan Impurity 1 Levosimendan Impurity 1 1643439-59-1 C22H23N7O2
Atomoxetine EP Impurity F Atomoxetine EP Impurity F
Quetiapine EP Impurity Q Quetiapine EP Impurity Q
Cefoxitin Impurity Cefoxitin Impurity
Acemetacin Impurity Acemetacin Impurity
ethyl (S)-6,7,8-trifluoro-1-(1-hydroxypropan-2-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl (S)-6,7,8-trifluoro-1-(1-hydroxypropan-2-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate 110548-03-3 C15H14F3NO4
Triamterene Related Compound B (50 mg) (2,7-diamino-4-hydroxy-6-phenylpteridine) Triamterene Related Compound B (50 mg) (2,7-diamino-4-hydroxy-6-phenylpteridine) 19375-89-4 C12H10N6O
IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin) IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin)
IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride 95062-18-3 C35H35ClF2N2
IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid
3,5-DiMethyl-1-nitroadaMantane 3,5-DiMethyl-1-nitroadaMantane 6588-68-7 C12H19NO2
2-Deschloro Aripiprazole 2-Deschloro Aripiprazole 203395-82-8 C23H28ClN3O2
6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 649761-24-0 C27H31N5O2Si
Desisobutyl-n-butyl BortezoMib Desisobutyl-n-butyl BortezoMib 1104011-35-9 C19H25BN4O4
2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 246512-44-7 C15H23N3O4
N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide 1402150-28-0 C8H9Cl2N3OS
Ebastine IMpurity G Ebastine IMpurity G 1429071-65-7 C32H39NO3
edaravone iMpurity edaravone iMpurity
(2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol C24H25FO5S
Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- 219843-76-2 C26H35NO2
ethyl (E)-2-(2-(4-methoxyphenyl)hydrazono)propanoate ethyl (E)-2-(2-(4-methoxyphenyl)hydrazono)propanoate 4792-57-8 C12H16N2O3
ACT 373898 ACT 373898 1433875-14-9 C15H17BrN4O5S
Reaxys ID: 3623864 Reaxys ID: 3623864 129385-61-1 C17H10ClNO3
Olaparib Impurity D Olaparib Impurity D
1-methylpyrrolidin-3-yl 2-(cyclopentyloxy)-2-phenylacetate 1-methylpyrrolidin-3-yl 2-(cyclopentyloxy)-2-phenylacetate C18H25NO3
Cabozantinib impurity A Cabozantinib impurity A
Loratadine Impurity 2 Loratadine Impurity 2 C22H23ClN2O2
Metoprolol Impurity 1 Metoprolol Impurity 1 C15H25NO3
Pitavastatin Impurity 1 Pitavastatin Impurity 1
Trifluridine Impurity 3 Trifluridine Impurity 3
Vonoprazan Impurity 1 Vonoprazan Impurity 1
Vonoprazan Impurity 4 Vonoprazan Impurity 4
Cinacalcet impurity K Cinacalcet impurity K
Valsartan Impurity 13 Valsartan Impurity 13 C24H29N5O3
Valsartan Impurity 27 Valsartan Impurity 27 C24H29N5O3
Etoricoxib Impurity 6 Etoricoxib Impurity 6
Ezetimibe impurity 3 Ezetimibe impurity 3
Apremilast Impurity C Apremilast Impurity C
bis(1-benzylpiperidin-3-yl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate bis(1-benzylpiperidin-3-yl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate 166808-97-5 C16H16N2O6
Ticagrelor Imp.J Ticagrelor Imp.J 2248538-63-6 C14H20ClN5O4S
Vortioxetine Imp.E Vortioxetine Imp.E 508233-77-0 C18H22N2S
(3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-07-6 C25H24FNO3
Topiroxostat Impurity 1 Topiroxostat Impurity 1
Oxcarbazepine Impurity3 Oxcarbazepine Impurity3
Mosapride  IMP Mosapride IMP
4-Ethoxy Paroxetine 4-Ethoxy Paroxetine 606968-04-1 C21H25NO4
Methylene-Bis Paroxetine Methylene-Bis Paroxetine 1292846-10-6 C39H40F2N2O6
Trelagliptin Impurity X Trelagliptin Impurity X 1938080-44-4 C18H22FN5O3
Afatinib Impurity 19 Afatinib Impurity 19 1245555-42-3 C21H21ClFN5O2
Cefoxitin Sodium impurity Cefoxitin Sodium impurity
(1S,2S,3S)-Aprepitant (1S,2S,3S)-Aprepitant 1242175-40-1 C23H21F7N4O3
2-{[(methoxycarbonylmethyl)(toluene-4-sulfonyl)amino]methyl}-4-phenoxybenzoic acid methyl ester 2-{[(methoxycarbonylmethyl)(toluene-4-sulfonyl)amino]methyl}-4-phenoxybenzoic acid methyl ester 1455091-06-1 C25H25NO7S
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