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:
- lansoprazole Impurity 29
- Structure:
- Chemical Name:
- Loratadine Impurity L
- MF:
- C22H23ClN2O2
- Chemical Name:
- meta-dyhydroxy Sugammadex sodium Impurity 1
- Structure:
- Chemical Name:
- Olanzapine impurity R
- MF:
- C17H20N4S
- Chemical Name:
- Palbociclib Impurity 33
- Chemical Name:
- Pramipexole Related Impurity 1
- Chemical Name:
- Ropivacaine Impurity 37
- Chemical Name:
- Ropivacaine Impurity 42
- Chemical Name:
- Sugammadex sodium Org197339-1 Impurity
- Structure:
- Chemical Name:
- Fludarabine EP impurity G
- CAS:
- 548774-56-7
- MF:
- C10H12ClFN5O6P
- Structure:
- Chemical Name:
- Sitagliptin Impurity 12
- CAS:
- 1803026-54-1
- MF:
- C16H12F6N4O
- Chemical Name:
- Afatinib impurity 30
- Structure:
- Chemical Name:
- Avibactam Impurity 45
- CAS:
- 2064219-20-9
- MF:
- C23H46N4O6S
- Structure:
- Chemical Name:
- Butyphthalide impurity 44
- CAS:
- 952413-01-3
- MF:
- C13H18O3
- Chemical Name:
- Cabozantinib impurity 24
- Structure:
- Chemical Name:
- Celecoxib Impurity 18
- CAS:
- 2271123-54-5
- MF:
- C11H9F3O2
- Chemical Name:
- Dapoxetine impurity 22
- Chemical Name:
- Febuxostat Impurity 85
- Chemical Name:
- Fosaprepitant Impurity NLS
- Structure:
- Chemical Name:
- Irinotecan Impurity 17 HCl
- CAS:
- 1332610-75-9
- MF:
- C19H14N2O4
- Chemical Name:
- LCZ696(valsartan + sacubitril) impurity 31
- Chemical Name:
- Lenvatinib Impurity 24
- Chemical Name:
- Lenvatinib Impurity 30
- Chemical Name:
- Regorafenib Impurity 22
- Chemical Name:
- Regorafenib Impurity 28
- Chemical Name:
- Sitafloxacin Impurity ZZ-C-01
- Structure:
- Chemical Name:
- Tofacitinib Impurity 85
- CAS:
- 2268720-86-9
- MF:
- C20H24ClN5
- Chemical Name:
- Tofacitinib Impurity 90
- Chemical Name:
- Nintedanib Impurity M
- Structure:
- Chemical Name:
- Citalopram Impurity 14
- CAS:
- 1470362-85-6
- MF:
- C20H23FN2O2
- Chemical Name:
- Eltrombopag Impurity 8
- Structure:
- Chemical Name:
- Vitexin 2''-O-beta-D-glucoside
- CAS:
- 61360-94-9
- MF:
- C27H30O15
- Structure:
- Chemical Name:
- (S)-methyl 2-(2,3-bis(hydroxymethyl)-6,7-dihydrothieno[3,2-c] pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate
- CAS:
- 1346231-36-4
- MF:
- C18H20ClNO4S
- Chemical Name:
- Capecitabine impurity 6
- Structure:
- Chemical Name:
- Vilanterol Impurity 25
- CAS:
- 1027529-99-2
- MF:
- C13H15NO4
- Chemical Name:
- Sugammadex sodium Org139131-1 Impurity
- Structure:
- Chemical Name:
- Dolutegravir Impurity 16
- CAS:
- 1357289-37-2
- MF:
- C20H19F2N3O5
- Chemical Name:
- N - hydroxy Tropisetron Impurity 2
- Chemical Name:
- Tofacitinib Impurity 98
- Chemical Name:
- Cabozantinib impurity 30
- Chemical Name:
- Cabozantinib impurity 35
- CAS:
- 1905820-17-8
- Structure:
- Chemical Name:
- Carvedilol Impurity DBA
- CAS:
- 3258-70-6
- MF:
- C18H23NO4
- Structure:
- Chemical Name:
- Pregabalin Impurity 9
- CAS:
- 44855-96-1
- MF:
- C5H7NO3
- Chemical Name:
- Butyphthalide impurity 50
- Chemical Name:
- Canagliflozin Impurity 40
- Structure:
- Chemical Name:
- Pralatrexate Impurity 4
- CAS:
- 1445586-42-4
- MF:
- C18H15N5O3
- Structure:
- Chemical Name:
- Pralatrexate Impurity 9
- CAS:
- 1548618-61-6
- MF:
- C23H22N6O6
- Chemical Name:
- Pitavastatin Impurity 47
- Chemical Name:
- Lenvatinib Impurity 38
- Chemical Name:
- Tazobactam Impurity 9
- Structure:
- Chemical Name:
- Doxofylline Impurity 11
- CAS:
- 109403-76-1
- MF:
- C15H16N8O4
- Chemical Name:
- Doxofylline Impurity 14
- Chemical Name:
- Canagliflozin Impurity 56
- Chemical Name:
- Canagliflozin Impurity 61
- Chemical Name:
- Tofacitinib Impurity 107
- Chemical Name:
- Hydroxychloroquine Impurity K
- Structure:
- Chemical Name:
- Levosimendan Impurity 8
- CAS:
- 274263-65-9
- MF:
- C14H14N6O2
- Chemical Name:
- Cabozantinib impurity R
- Chemical Name:
- Rotigotine Impurity 4
- Chemical Name:
- Crisaborole Impurity 4
- Chemical Name:
- Crisaborole Impurity 9
- Chemical Name:
- Trifluridine Impurity C
- Structure:
- Chemical Name:
- Olprinone Impurity 3
- CAS:
- 1402751-73-8
- MF:
- C14H11N3O3
- Chemical Name:
- Olprinone Impurity 8
- Structure:
- Chemical Name:
- (R)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride
- CAS:
- 117707-39-8
- MF:
- C17H18FN3O4
- Chemical Name:
- Nicorandil Impurity G
- Structure:
- Chemical Name:
- Bivalirudin Impurity 3
- CAS:
- 1310025-28-5
- MF:
- C98H138N24O33
- Chemical Name:
- Cilastatin Impurity 3
- Structure:
- Chemical Name:
- Solifenacin Impurity 7（Solifenacin EP Impurity D）
- CAS:
- 2216750-52-4
- MF:
- C31H28N2O
- Structure:
- Chemical Name:
- Dyclonine Impurity 2
- CAS:
- 66536-15-0
- MF:
- C13H16O2
- Structure:
- Chemical Name:
- Cefuroxime Impurity 33
- CAS:
- 929531-94-2
- MF:
- C16H16N4O9S
- Chemical Name:
- Ondansetron IMpurity 4
- Chemical Name:
- MeropeneM iMpurity 3
- Chemical Name:
- MeropeneM iMpurity 8
- Structure:
- Chemical Name:
- Metronidazole Impurity 13
- CAS:
- 110578-73-9
- MF:
- C6H9N3O3
- Structure:
- Chemical Name:
- Eletriptan Impurity 4
- CAS:
- 1422285-51-5
- MF:
- C44H50N4O4S2
- Chemical Name:
- Afatinib Impurity 51
- Chemical Name:
- Afatinib Impurity 66
- Structure:
- Chemical Name:
- Brivaracetam Impurity 10
- CAS:
- 60559-16-2
- MF:
- C10H20O2
- Chemical Name:
- Cabozantinib Impurity 6
- Chemical Name:
- Empagliflozin Impurity 59
- Chemical Name:
- Fulvestrant Impurity 12
- Chemical Name:
- Linagliptin Impurity 56
- Chemical Name:
- Linagliptin Impurity 61
- Structure:
- Chemical Name:
- Ornidazole Impurity 16
- CAS:
- 1565482-62-3
- MF:
- C7H11ClN2O
- Chemical Name:
- Oseltamivir Impurity 46
- Chemical Name:
- Oseltamivir Impurity 53
- Chemical Name:
- Palbociclib Impurity 66
- Structure:
- Chemical Name:
- Peramivir Impurity 13
- CAS:
- 2641684-79-7
- MF:
- C13H27ClN4O3
- Chemical Name:
- Pimecrolimus Impurity 2
- Chemical Name:
- Rosuvastatin Impurity 81
- Chemical Name:
- Rosuvastatin Impurity 102
- Chemical Name:
- Tazobactam Impurity 14
- Chemical Name:
- Ticagrelor Impurity 124
- Chemical Name:
- Tofacitinib Impurity 113
- Chemical Name:
- Voriconazole Impurity 20
- Chemical Name:
- Carbocistein Impurity F
- Chemical Name:
- Cilastatin EP Impurity B
- Structure:
- Chemical Name:
- Olaparib Impurity 14
- CAS:
- 2250242-62-5
- MF:
- C36H28F2N6O4
- Chemical Name:
- Brimonidine Impurity B