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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
Rotigotine Impurity 2 Rotigotine Impurity 2
Rotigotine Impurity 9 Rotigotine Impurity 9
Olprinone Impurity 5 Olprinone Impurity 5
Vitamin B5 Impurity 1 Vitamin B5 Impurity 1 897045-90-8 C12H22N2O6
Cilastatin Impurity 5 Cilastatin Impurity 5
(R)-3-(4-(2-chloro-5-iodobenzyl)phenoxy)tetrahydrofuran (R)-3-(4-(2-chloro-5-iodobenzyl)phenoxy)tetrahydrofuran 2194590-02-6 C17H16ClIO2
Sitagliptin Impurity 69 Sitagliptin Impurity 69 2172430-88-3 C15H16F3NO4
Dimethyl (1-Diazo-2-oxopropyl)phosphonate Dimethyl (1-Diazo-2-oxopropyl)phosphonate 90965-06-3 C5H9N2O4P
Trimetazidine Impurity 8 Trimetazidine Impurity 8
MeropeneM iMpurity 5 MeropeneM iMpurity 5
Perindopril IMpurity 6 Perindopril IMpurity 6 2163775-15-1 C8H15NO4
Oseltamivir Impurity 48 Oseltamivir Impurity 48 651324-04-8 C18H33NO4
Tamsulosin impurity 5 Tamsulosin impurity 5 C20H28N2O5S
Flucloxacillin Impurity 5 Flucloxacillin Impurity 5
Nitrendipine iMpurity G Nitrendipine iMpurity G
(S)-N-(5-((S)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide (S)-N-(5-((S)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide 2409589-59-7 C21H22F2N6O2
Afatinib Impurity 53 Afatinib Impurity 53
Afatinib Impurity 68 Afatinib Impurity 68
(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
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
Alogliptin Impurity 26 Alogliptin Impurity 26
Empagliflozin Impurity 61 Empagliflozin Impurity 61
Ipragliflozin Impurity 3 Ipragliflozin Impurity 3 1922933-61-6
Isavuconazole Impurity 30 Isavuconazole Impurity 30
Levetiracetam Impurity 27 Levetiracetam Impurity 27
Linagliptin Impurity 58 Linagliptin Impurity 58
Oseltamivir Impurity 33 Oseltamivir Impurity 33
Oseltamivir Impurity 49 Oseltamivir Impurity 49
Palbociclib Impurity 52 Palbociclib Impurity 52
Palbociclib Impurity 37 Palbociclib Impurity 37
Pazufloxacin Impurity 16 Pazufloxacin Impurity 16 165071-10-3 C14H10FNO6
Pimecrolimus Impurity 4 Pimecrolimus Impurity 4
Posaconazole Impurity 73 Posaconazole Impurity 73
Rosuvastatin Impurity 90 Rosuvastatin Impurity 90 2226413-62-1 C38H44F2N6O8S2
Tofacitinib Impurity 110 Tofacitinib Impurity 110
Tofacitinib Impurity 115 Tofacitinib Impurity 115
Trelagliptin Impurity 27 Trelagliptin Impurity 27
Vildagliptin Impurity 30 Vildagliptin Impurity 30 918830-94-1 C10H17NO2
N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d] pyrimidin-2-amine N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d] pyrimidin-2-amine C13H19N5
Tolvaptan Impurity 6 Tolvaptan Impurity 6 1432725-24-0 C18H19ClN2O2
Esmolol impurity B Esmolol impurity B
Esmolol impurity F Esmolol impurity F
Diquafosol Impurity E Diquafosol Impurity E
Bortezomib Impurity 39 Bortezomib Impurity 39
Agomelatine Impurity 1 Agomelatine Impurity 1
Sunitinib Impurity 5 Sunitinib Impurity 5
Silodosin Impurity 6 Silodosin Impurity 6
Erlotinib Impurity 19 Erlotinib Impurity 19
Ticagrelor Impurity 40 Ticagrelor Impurity 40
Moxifloxacin Impurity 12 Moxifloxacin Impurity 12
Cabozantinib Impurity 4 Cabozantinib Impurity 4
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
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
(-)-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
ETHYL 3,4-EPOXYBUTANOATE ETHYL 3,4-EPOXYBUTANOATE 32223-97-5 C6H10O3
(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
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
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