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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- Chemical Name:
- Regorafenib Impurity 26
- Chemical Name:
- Sitafloxacin Impurity ZZ-B-01
- Structure:
- Chemical Name:
- Tofacitinib Impurity 3
- CAS:
- 1206825-36-6
- MF:
- C13H19N5
- Chemical Name:
- Tofacitinib Impurity 89
- Structure:
- Chemical Name:
- Nintedanib Impurity L
- CAS:
- 2095596-44-2
- MF:
- C31H33N5O4
- Structure:
- Chemical Name:
- (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,11,13- pentahydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6- azacyclopentadecan-15-one
- CAS:
- 117693-42-2
- MF:
- C22H43NO7
- Structure:
- Chemical Name:
- Rizatriptan EP Impurity A
- CAS:
- 887001-08-3
- MF:
- C28H35N7
- Structure:
- Chemical Name:
- Dapoxetine iMpurity
- CAS:
- 38262-42-9
- MF:
- C11H10O3S
- Chemical Name:
- Eltrombopag Impurity 7
- Chemical Name:
- Saxagliptin Impurity 9
- Structure:
- Chemical Name:
- (1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol
- CAS:
- 15992-77-5
- MF:
- C15H22N2O5
- Chemical Name:
- Moxifloxacin degrade Impurity
- Chemical Name:
- Edaravone Impurity 17
- Chemical Name:
- Capecitabine impurity 7
- Chemical Name:
- Linagliptin Impurity 46
- Structure:
- Chemical Name:
- ((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II)
- MF:
- C44H56CaN6O12S2
- Structure:
- Chemical Name:
- Levofloxacin Impurity 24
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- (trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide
- CAS:
- 1932275-13-2
- MF:
- C10H9F2NO
- Structure:
- Chemical Name:
- (3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II)
- CAS:
- 1445208-17-2
- MF:
- C22H28FN3O6S
- Structure:
- Chemical Name:
- Tafluprost Impurity 7
- CAS:
- 733036-94-7
- MF:
- C25H35FO5
- Chemical Name:
- Tropisetron Impurity 1
- Chemical Name:
- Fosaprepitant Impurity DBJ
- Chemical Name:
- Cabozantinib impurity 29
- Chemical Name:
- Cabozantinib impurity 34
- Chemical Name:
- Carfilzomib Impurity YGH
- Chemical Name:
- Ondansetron Impurity 3
- Chemical Name:
- Irsogladine Impurity GDT
- Chemical Name:
- Carvedilol Impurity NH
- Structure:
- Chemical Name:
- Pregabalin Impurity 8
- CAS:
- 44996-52-3
- MF:
- C7H11NO3
- Structure:
- Chemical Name:
- Pregabalin Impurity 14
- CAS:
- 1610546-44-5
- MF:
- C7H11NO3
- Chemical Name:
- Cefditoren Impurity 1
- Structure:
- Chemical Name:
- Cefadroxil Impurity C
- CAS:
- 79962-91-7
- MF:
- C16H17N3O5S
- Structure:
- Chemical Name:
- Pralatrexate Impurity 8
- CAS:
- 112408-16-9
- MF:
- C8H15NO4
- Chemical Name:
- Pitavastatin Impurity 46
- Chemical Name:
- Canagliflozin Impurity 46
- Chemical Name:
- Lenvatinib Impurity 37
- Chemical Name:
- Sitafloxacin Impurity 20
- Chemical Name:
- posaconazole impurity 66
- Chemical Name:
- Dapoxetine impurity 33
- Chemical Name:
- Budesonide Impurity 4
- Chemical Name:
- Atracurium Impurity 31
- Structure:
- Chemical Name:
- Canagliflozin Impurity 49
- CAS:
- 2243132-56-9
- MF:
- C34H35FO11S
- Chemical Name:
- Canagliflozin Impurity 55
- Chemical Name:
- Rosuvastatin Impurity 74
- Chemical Name:
- Tofacitinib Impurity 106
- Chemical Name:
- Hydroxychloroquine Impurity J
- Chemical Name:
- Levetiracetam Impurity 25
- Chemical Name:
- Levosimendan Impurity 7
- Chemical Name:
- Cabozantinib impurity K
- Chemical Name:
- Crisaborole Impurity 8
- Chemical Name:
- Trifluridine Impurity B
- Chemical Name:
- Rotigotine Impurity
- Structure:
- Chemical Name:
- Olprinone Impurity 2
- CAS:
- 106730-62-5
- MF:
- C14H12N4O2
- Chemical Name:
- Nicorandil Impurity F
- Structure:
- Chemical Name:
- M-ISOBUTYL IBUPROFEN
- CAS:
- 66622-47-7
- MF:
- C13H18O2
- Structure:
- Chemical Name:
- 1,3-BIS(METHYLTHIO)-2-PROPANOL
- CAS:
- 31805-83-1
- MF:
- C5H12OS2
- Structure:
- Chemical Name:
- 4-ISOTHIOCYANATO-4'-NITRODIPHENYL ETHER
- CAS:
- 19881-18-6
- MF:
- C13H8N2O3S
- Structure:
- Chemical Name:
- Amlodipine Impurity 22 (Z-Isomer)
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- Amlodipine Impurity 28
- CAS:
- 79781-21-8
- MF:
- C18H20ClNO5
- Chemical Name:
- Axitinib Impurity 16
- Chemical Name:
- Axitinib Impurity 22
- Structure:
- Chemical Name:
- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-
- CAS:
- 448184-48-3
- MF:
- C23H32N6O5S
- Structure:
- Chemical Name:
- Dolutegravir 4-Desfluoro Impurity
- CAS:
- 1863916-87-3
- MF:
- C20H20FN3O5
- Structure:
- Chemical Name:
- Tetrabenazine Dehydro Impurity
- CAS:
- 100322-43-8
- MF:
- C19H25NO3
- Structure:
- Chemical Name:
- Cefotiam Impurity 22
- CAS:
- 1628441-07-5
- MF:
- C13H14N4O5S2
- Structure:
- Chemical Name:
- Dezocine Impurity 2
- CAS:
- 100667-17-2
- MF:
- C16H21NO
- Structure:
- Chemical Name:
- loteprednol Impurity 7
- CAS:
- 82034-20-6
- MF:
- C24H33ClO7
- Structure:
- Chemical Name:
- Sitagliptin Impurity 28
- CAS:
- 898543-70-9
- MF:
- C32H25F12N9O2
- Structure:
- Chemical Name:
- Vilanterol Impurity 3 Triphenylacetate
- CAS:
- 503070-62-0
- MF:
- C23H31Cl2NO5
- Chemical Name:
- Empagliflozin Impurity 33
- Structure:
- Chemical Name:
- Sugammadex Impurity 21
- CAS:
- 2412952-93-1
- MF:
- C72H113NaO48S8
- Structure:
- Chemical Name:
- 4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzaldehyde trihydrochloride
- CAS:
- 1254176-45-8
- MF:
- C18H30N4O
- Chemical Name:
- Cefminox Sodium impurity 5
- Chemical Name:
- Nicorandil Impurity A
- Structure:
- Chemical Name:
- Tolvaptan Impurity 35
- CAS:
- 1316312-24-9
- MF:
- C10H10ClN
- Chemical Name:
- Erythromycin Impurity F
- Chemical Name:
- Apixaban Impurity 39
- Chemical Name:
- Aztreonam Impurity 1
- Chemical Name:
- Axitinib Impurity 1
- Chemical Name:
- Aprepitant Impurity 15
- Structure:
- Chemical Name:
- Trelagliptin Impurity 17
- CAS:
- 865759-02-0
- MF:
- C17H20BrFN4O2
- Chemical Name:
- Dapoxetine Impurity 1
- CAS:
- 2825577-69-1
- Chemical Name:
- Regorafenib Impurity 15
- Chemical Name:
- Flomoxef Impurity 2
- Chemical Name:
- Varenicline Impurity 2
- Chemical Name:
- Topiroxostat Impurity 5
- Chemical Name:
- Everolimus Impurity 5
- Chemical Name:
- Ibrutinib Impurity 3
- Chemical Name:
- Canagliflozin Impurity 9
- Structure:
- Chemical Name:
- Clopidogrel Impurity 14
- MF:
- C15H14ClNO2S
- Chemical Name:
- Febuxostat Impurity 53
- Chemical Name:
- Cefodizime Impurity C
- Chemical Name:
- Riociguat IMpurtiy F
- Chemical Name:
- Acrivastine Impurity 1
- Structure:
- Chemical Name:
- Nifedipine impurity 10
- CAS:
- 10323-98-5
- MF:
- C13H13NO3
- Chemical Name:
- Cefminox Sodium impurity E
- Chemical Name:
- Clindamycin Impurity D
- Chemical Name:
- Fasudil iMpurity C
- Chemical Name:
- Cefminox Impurity D
- Structure:
- Chemical Name:
- SORAFENIB N-OXIDE
- CAS:
- 583840-03-3
- MF:
- C21H16ClF3N4O4