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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
Ribavirin Impurity I Ribavirin Impurity I
Silodosin Impurity 2 Silodosin Impurity 2
Tenofovir Impurity 52 Tenofovir Impurity 52 146297-30-5
Amifostine Impurity 7 Amifostine Impurity 7 174397-83-2 C7H16Br2N2
Amphotericin X1 (13-O-Methyl Amphotericin B) Amphotericin X1 (13-O-Methyl Amphotericin B) 136135-57-4 C48H75NO17
Bendamustine Impurity 31 Bendamustine Impurity 31
Carbidopa Impurity 2 Carbidopa Impurity 2 1361017-74-4 C11H16N2O4
Cefazolin Impurity 2 Cefazolin Impurity 2
Cefminox Sodium Impurity 8 Cefminox Sodium Impurity 8
Dapagliflozin Impurity 28 Dapagliflozin Impurity 28
Erlotinib Impurity 51 Erlotinib Impurity 51 115665-66-2 C8H6BrNO2
Oseltamivir Impurity 18 Oseltamivir Impurity 18
Plerixafor Impurity 6 Plerixafor Impurity 6
Pregabalin Impurity 49 Pregabalin Impurity 49 1568110-05-3 C10H21NO2
Rivaroxaban Impurity 79 Rivaroxaban Impurity 79 1642601-00-0 C38H38N4O12
Rocuronium Bromide Impurity 37 Rocuronium Bromide Impurity 37
Rosuvastatin Impurity 4 Rosuvastatin Impurity 4 1899869-35-2 C19H22FN3O3S
S,S-Efinaconazole S,S-Efinaconazole 164650-45-7 C18H22F2N4O
BendaMustine IMpurity BendaMustine IMpurity
Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester 85014-68-2 C11H13ClN2O3
D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester 1496552-28-3 C22H29FN3O9P
D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)- 842133-16-8 C24H26O5S
Phthalic acid, 3,3'-azoxydi- (8CI) Phthalic acid, 3,3'-azoxydi- (8CI) 22895-28-9 C16H10N2O9
(alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile (alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile 1150310-15-8 C15H15N3O5
(2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide (2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 857629-79-9 C16H19N3O5
(R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate (R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate 149709-59-1 C25H31NO4
1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97% 1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97% 20529-23-1 C14H23N3O
(2S,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2S,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-54-6 C23H29NO4
Calcium bis[4-{[(1S,3R)-1-([1,1'-biphenyl]-4-ylmethyl)-3-methyl-4-oxo-4-(propan-2-yloxyl)butyl]amino}-4-oxobutanoate] Calcium bis[4-{[(1S,3R)-1-([1,1'-biphenyl]-4-ylmethyl)-3-methyl-4-oxo-4-(propan-2-yloxyl)butyl]amino}-4-oxobutanoate] C50H60CaN2O10
3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzamide 3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzamide 917391-28-7 C12H10F3N3O
Alogliptin Impurity E Alogliptin Impurity E
Alogliptin Impurity E Alogliptin Impurity E
Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester 830346-51-5 C33H32F5N3O5
Baicalein 6-O-glucoside Baicalein 6-O-glucoside 28279-72-3 C21H20O10
(2S,3R)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butane-2,3-diol (2S,3R)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butane-2,3-diol 135272-36-5 C12H13F2N3O2
Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-5,6,7,8,9,10-hexahydro-4-phenyl- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-5,6,7,8,9,10-hexahydro-4-phenyl- 132810-75-4 C23H31N3
(R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)propan-1-one (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)propan-1-one 1839099-22-7 C25H26N6O2
Linagliptin Impurity L Linagliptin Impurity L
Linagliptin Impurity S Linagliptin Impurity S 668273-74-3 C30H36N8O4
(R)-2-((6-(3-aminopiperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile (R)-2-((6-(3-aminopiperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile C17H18FN5O2
Olaparib impurity 1 Olaparib impurity 1 763113-06-0 C24H24N4O3
4-Quinazolinamine,N-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-,hydrochloride(1:1) 4-Quinazolinamine,N-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-,hydrochloride(1:1) 1624294-38-7 C22H26ClN3O4
4-Oxiranylmethoxy-benzaldehyde 4-Oxiranylmethoxy-benzaldehyde 14697-49-5 C10H10O3
Alogliptin Related Compound 24 Alogliptin Related Compound 24 1430222-06-2 C14H12ClN3O2
Apremilast Impurity 1 Apremilast Impurity 1
Etoricoxib Impurity 15 Etoricoxib Impurity 15 73312-69-3 C5H8ClNO
Ibrutinib Impurity 1 Ibrutinib Impurity 1
Mirabegron Impurity 13 Mirabegron Impurity 13
Riociguat Impurtiy 4 Riociguat Impurtiy 4
2,3-Dehydrosilybin  B 2,3-Dehydrosilybin B 142796-24-5 C25H20O10
2(1H)-Pyrimidinone,4-amino-1-b-D-arabinofuranosyl-, 3-oxide 2(1H)-Pyrimidinone,4-amino-1-b-D-arabinofuranosyl-, 3-oxide 30902-36-4 C9H13N3O6
3,5-Pyridinedicarboxylicacid, 4-(2-chlorophenyl)-1,4-dihydro-2,6-dimethyl-, 3,5-diethyl ester 3,5-Pyridinedicarboxylicacid, 4-(2-chlorophenyl)-1,4-dihydro-2,6-dimethyl-, 3,5-diethyl ester 34148-67-9 C19H22ClNO4
1-Propanamine,3-(dibenz[b,e]oxepin-11(6H)-ylidene)-N,N-dimethyl-, hydrochloride (1:1), (3Z)- 1-Propanamine,3-(dibenz[b,e]oxepin-11(6H)-ylidene)-N,N-dimethyl-, hydrochloride (1:1), (3Z)- 25127-31-5 C19H22ClNO
Phenol, 4-(hydroxyamino)- Phenol, 4-(hydroxyamino)- 3505-87-1 C6H7NO2
Cabozantinib Impurity Cabozantinib Impurity 1355031-15-0 C16H14N2O3
Canagliflozin open-ring impurity Canagliflozin open-ring impurity
Dapoxetine Impurity E Dapoxetine Impurity E
Ilaprazole Impurity Ilaprazole Impurity 1018229-53-2 C11H9N3O
Linagliptin Impurity X Linagliptin Impurity X
Norfloxacin Imp.(EP) Norfloxacin Imp.(EP) 1911573-08-4 C34H52FN3O4
Ondansetron EP Impurity H Ondansetron EP Impurity H 201409-17-8 C17H18ClN3O
Rocuronium Bromide Impurity Rocuronium Bromide Impurity 13492-57-4 C27H44N2O4
Ruxolitinib  Impurity Ruxolitinib Impurity
Roxithromycin h Roxithromycin h
Ixazomib Impurity 2 Ixazomib Impurity 2
sildenafil impurity I sildenafil impurity I C22H30N6O4S
2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni 2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni 120511-92-4 C17H19N5
2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni 2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni 120511-92-4 C17H19N5
Benzoic acid, 4-(3-hydroxy-1-propenyl)-, ethyl ester Benzoic acid, 4-(3-hydroxy-1-propenyl)-, ethyl ester 89113-43-9 C12H14O3
1-((2S,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione 1-((2S,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione 2041584-99-8 C10H13FN2O5
2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 1353428-89-3 C13H17NO
2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 1353428-89-3 C13H17NO
Dapoxetine Impurity 13 Dapoxetine Impurity 13 156453-50-8 C19H18O2
Terbutaline  Impurity 4 Terbutaline Impurity 4 52144-92-0 C33H35NO3
5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine 5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine 1823404-28-9 C9H11BrClN3
(3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid (3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid 1714147-47-3 C25H36CaFN3O7S
delphinidin 3-O-beta-D-glucoside delphinidin 3-O-beta-D-glucoside 50986-17-9 C21H21O12+
isorhamnetin 7-O-beta-D-glucopyranoside isorhamnetin 7-O-beta-D-glucopyranoside 6743-96-0 C22H22O12
N-(2,6-dimethylphenyl)nicotinamide N-(2,6-dimethylphenyl)nicotinamide 84951-65-5 C14H14N2O
Difluoro Atorvastatin Acetonide tert-Butyl Ester Difluoro Atorvastatin Acetonide tert-Butyl Ester 693793-87-2 C40H46F2N2O5
Tirofiban hydrochloride Impurity 6 Tirofiban hydrochloride Impurity 6 2250244-31-4 C17H27NO7S2
Demiditraz IMpurity Demiditraz IMpurity 944268-65-9 C20H20N2
Aprepitant Impurity 16 Aprepitant Impurity 16 850354-60-8
Aripiprazole impurity 20 Aripiprazole impurity 20 203395-83-9
Aripiprazole impurity 20 Aripiprazole impurity 20 203395-83-9
Blonanserin impurity H Blonanserin impurity H
Captopril impurity 1 Captopril impurity 1
Cefodizime Impurity 6 Cefodizime Impurity 6
Clindamycin Impurity 5 Clindamycin Impurity 5
Dapoxetine Impurity 16 Dapoxetine Impurity 16
Doxofylline Impurity 5 Doxofylline Impurity 5
Everolimus impurity B Everolimus impurity B
FeBuxostat Impurity 27 FeBuxostat Impurity 27
Fosaprepitant Impurity 1 Fosaprepitant Impurity 1 172822-01-4 C23H22F7N4O6P
Hydroxychloroquine Impurity 7 Hydroxychloroquine Impurity 7 47493-14-1 C20H28ClN3O2
Indacaterol Impurity 12 Indacaterol Impurity 12 1026461-20-0 C22H24N2O3
Isavuconazole Impurity 15 Isavuconazole Impurity 15
Isavuconazole Impurity 3 Isavuconazole Impurity 3
Isavuconazole Impurity 8 Isavuconazole Impurity 8
Lenvatinib Impurity 3 Lenvatinib Impurity 3
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