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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
rac N-Desbutyroyl Acebutolol rac N-Desbutyroyl Acebutolol 57898-80-3 C14H22N2O3
rac-Clopidogrel-MP Endo Derivative rac-Clopidogrel-MP Endo Derivative 1346598-12-6 C25H26ClNO6S
1,1'-N-[Methylenebis(sulphanediylethylene)]bis(N'-Methyl-2-nitroethene-1,1-diaMine 1,1'-N-[Methylenebis(sulphanediylethylene)]bis(N'-Methyl-2-nitroethene-1,1-diaMine 1331637-48-9 C11H22N6O4S2
ent-LaMivudine ent-LaMivudine 134680-32-3 C8H11N3O3S
Formoterol O-β-D-Glucuronide Formoterol O-β-D-Glucuronide 615551-59-2 C25H32N2O10
Mono-POC Tenofovir 6-Isopropyl CarbaMate Mono-POC Tenofovir 6-Isopropyl CarbaMate 1244022-56-7 C18H28N5O9P
N-Methyl Iso Desloratadine N-Methyl Iso Desloratadine 183198-48-3 C20H21ClN2
Tartaric Acid Isopropyl Ester Tartaric Acid Isopropyl Ester 116601-09-3 C7H12O6
Vardenafil Acetyl Analogue Vardenafil Acetyl Analogue 1261351-28-3 C25H34N6O3
3-(3-TRIFLUOROMETHYL-PHENYL)-PROPYLAMINE 3-(3-TRIFLUOROMETHYL-PHENYL)-PROPYLAMINE 104774-87-0 C10H12F3N
4-(3,4-Dichloro-phenyl)-3,4-dihydro-2H-naphthalen-1-one 4-(3,4-Dichloro-phenyl)-3,4-dihydro-2H-naphthalen-1-one 124379-29-9 C16H12Cl2O
(4-(2-(azepan-1-yl)ethoxy)phenyl)Methanol (4-(2-(azepan-1-yl)ethoxy)phenyl)Methanol 223251-16-9 C15H23NO2
4-HYDROXY PROPOFOL 4-HYDROXY PROPOFOL 1988-10-9 C12H18O2
Ozagrel methylester Ozagrel methylester 866157-50-8 C13H12N2O2
2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 163685-38-9 C15H25NO3
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 130793-30-5 C22H44O4
Ribavirin Related Compound A (15 mg) (1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid) Ribavirin Related Compound A (15 mg) (1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid) 39925-19-4 C8H11N3O6
3-cyano-4-isobutoxybenzaMide 3-cyano-4-isobutoxybenzaMide 161718-85-0 C12H14N2O2
Caffeidinecarboxylic acid Caffeidinecarboxylic acid 54536-15-1 C8H12N4O3
1-Keto BaMbuterol 1-Keto BaMbuterol 112935-94-1 C18H27N3O5
7-Chloro-4-(4-hydroxyanilino)quinoline 7-Chloro-4-(4-hydroxyanilino)quinoline 81099-86-7 C15H11ClN2O
Desfluoro EzetiMibe Desfluoro EzetiMibe 302781-98-2 C24H22FNO3
8-Iodo-1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane 8-Iodo-1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane 109574-84-7 C14H16F13I
5-(2-Bromo-1-oxobutyl)-8-hydroxy-2(1H)-quinolinone 5-(2-Bromo-1-oxobutyl)-8-hydroxy-2(1H)-quinolinone 59827-93-9 C13H12BrNO3
2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 320347-97-5 C17H19NO3S2
benzbroMarone iMpurity benzbroMarone iMpurity
Dasatinib iMpurity Dasatinib iMpurity 1184919-23-0 C22H27N7O2S
eszopiclone iMpurity eszopiclone iMpurity
IMidafenacin iMpurity IMidafenacin iMpurity 503599-41-5 C18H20N2O2
latanoprost iMpurity latanoprost iMpurity 733036-95-8 C25H35FO5
Irbesartan IMpurity D Irbesartan IMpurity D C25H28N6O
Ondansetron HCl IMpurity-G Ondansetron HCl IMpurity-G 99614-03-6 C17H17N3O
lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate 1421227-96-4 C9H11LiO4S
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) 120512-03-0 C17H21N5O
AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer) AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer)
ApreMilast IMpurity ApreMilast IMpurity 2438558-63-3 C21H22N2O7S
5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 381233-79-0 C10H7BrN2O
1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 2243786-01-6 C30H35N5O3
5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
EMpagliflozin  iMpurity 8 EMpagliflozin iMpurity 8
EMpagliflozin  iMpurity 13 EMpagliflozin iMpurity 13 2125472-55-9 C23H25ClO8
6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 1365727-07-6 C27H26N2O2
(-)-Syringaresinol-4-O-beta-D-glucopyranoside (-)-Syringaresinol-4-O-beta-D-glucopyranoside 137038-13-2 C28H36O13
Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) 910299-74-0 C19H24O4
Etoricoxib Impurity 12 Etoricoxib Impurity 12 646459-41-8 C21H16ClN3O2S
Levofloxacin Tetrafluoro Impurity 2 Levofloxacin Tetrafluoro Impurity 2 103995-33-1 C14H12F4O4
Mupirocin Impurity C Mupirocin Impurity C C26H44O9
Verapamil Impurity H Verapamil Impurity H 67018-83-1 C26H36N2O4
Warfarin Impurity 1 Warfarin Impurity 1 55901-61-6 C13H14O
Vitexin -4''-O-glucoside Vitexin -4''-O-glucoside 178468-00-3 C27H30O15
Aripiprazole EP impurity D Aripiprazole EP impurity D
Macitentan impurity B Macitentan impurity B 441796-13-0 C18H18Br2N6O4S
Meropenem IMP B Meropenem IMP B
tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate 412348-27-7 C14H20BrN3O2
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 21881-78-7 C21H26N2O6
2-(4-Methylphenyl)sulfonyloxyethanol 2-(4-Methylphenyl)sulfonyloxyethanol 42772-85-0 C9H12O4S
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 1564265-94-6 C18H25N3O2
(2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-56-8 C23H29NO4
Alogliptin Impurity A Alogliptin Impurity A
Linagliptin Impurity D Linagliptin Impurity D 666816-91-7 C20H28N6O4
Parecoxib Impurity C Parecoxib Impurity C 3026677-40-4
Rac Atomoxetine Hydrochloride Rac Atomoxetine Hydrochloride 82857-40-7 C17H22ClNO
3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 943320-48-7 C10H8F3N3
Linagliptin Impurity H Linagliptin Impurity H 1646355-34-1 C22H23N7O2
Ezetimibe Impurity 54 Ezetimibe Impurity 54 1185883-39-9 C40H36F2N2O5
2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 1348664-75-4 C13H13FN6O
Dapagliflozin Impurity 2 Dapagliflozin Impurity 2
Imatinib Impurity 1 Imatinib Impurity 1
Imatinib Impurity 6 Imatinib Impurity 6
Nifedipine Impurity 3 Nifedipine Impurity 3 C19H22N2O6
Riociguat Impurtiy 5 Riociguat Impurtiy 5
Vonoprazan Impurity 6 Vonoprazan Impurity 6
Avibactam Impurity Avibactam Impurity 1797133-98-2 C7H12N3NaO6S
Citalopram EP Impurity E Citalopram EP Impurity E 64169-47-7 C19H22Cl2FNO
Dapagliflozin Impurity F Dapagliflozin Impurity F
Dapoxetine Impurity A Dapoxetine Impurity A
Entecavir  Impurity Entecavir Impurity 1333204-94-6 C12H15N5O3
Gadobutrol Impurity Gadobutrol Impurity 71231-87-3 C7H15NO5
Lesinurad Impurity Lesinurad Impurity
Pramipexole Impurity G Pramipexole Impurity G
Salmeterol EP Impurity A Salmeterol EP Impurity A 1798014-51-3 C19H25NO3
Tacrolimus impurity D Tacrolimus impurity D
2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 202189-77-3 C32H44N4O2
Saxagliptin Impurity 6 Saxagliptin Impurity 6
Alcaftadine N-Oxide Alcaftadine N-Oxide 952649-75-1 C19H21N3O2
Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate 202534-94-9 C15H16FNO4
Tofacitinib Impurity H Tofacitinib Impurity H
3',6'-Dehydroclindamycin 3',6'-Dehydroclindamycin 1440605-51-5 C18H31ClN2O5S
Iguratimod Impurity 5 Iguratimod Impurity 5 84594-95-6 C13H11NO4
Cefradine Impurity F Cefradine Impurity F
Mirabegron Impurity Mirabegron Impurity 1684452-83-2 C26H28N6O3S2
1-methyl-1H-indol-6-ol 1-methyl-1H-indol-6-ol 130570-60-4 C9H9NO
2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 118485-48-6 C13H13NO3S
FLUORIDE STANDARD FLUORIDE STANDARD 16984-48-8 F-
32-Carboxycyanocobalamin 32-Carboxycyanocobalamin 121483-62-3 C63H87CoN13O15P
Alvimopan Impurity 6 Alvimopan Impurity 6
Acarbose Impurity B Acarbose Impurity B
Sofosbuvir Impurity28 Sofosbuvir Impurity28
Rivaroxaban Impurity 10 Rivaroxaban Impurity 10
Ipragliflozin Impurity 1 Ipragliflozin Impurity 1
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