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:
- Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester
- CAS:
- 477877-98-8
- MF:
- C26H40O5
- Structure:
- Chemical Name:
- 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide
- CAS:
- 1997296-62-4
- MF:
- C13H12F2N6O2
- Structure:
- Chemical Name:
- para-Hydroxy L-Milnacipran
- CAS:
- 688738-11-6
- MF:
- C15H22N2O2
- Chemical Name:
- Varenicline Impurity 9
- Chemical Name:
- Elagolix Sodium impurity3
- Structure:
- Chemical Name:
- Epinephrine Impurity 4
- CAS:
- 94217-53-5
- MF:
- C9H13NO3
- Structure:
- Chemical Name:
- (trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O
- Structure:
- Chemical Name:
- TIZOXANIDE GLUCURONIDE, SODIUM SALT
- CAS:
- 221287-83-8
- MF:
- C16H14N3NaO10S
- Structure:
- Chemical Name:
- ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE
- CAS:
- 28663-68-5
- MF:
- C10H11ClN2O2
- Structure:
- Chemical Name:
- Pyrido[4,3-d]pyrimidine-2,4,7(1H,3H,6H)-trione, 1-(3-aminophenyl)-3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-
- CAS:
- 871701-87-0
- MF:
- C24H21FIN5O3
- Chemical Name:
- 7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
- Chemical Name:
- IOHEXOL RELATED COMPOUND C (100 MG) (N,N'- BIS(2,3-DIHYDROXYPROPYL)-5-NITRO-1,3-BENZENEDI- CARBOXAMIDE)
- Structure:
- Chemical Name:
- N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE
- CAS:
- 81403-69-2
- MF:
- C14H22ClN5O2
- Structure:
- Chemical Name:
- FAMOTIDINE RELATED COMPOUND B
- CAS:
- 89268-62-2
- MF:
- C16H23N11O2S5
- Structure:
- Chemical Name:
- 1026009-77-7
- CAS:
- 1026009-77-7
- MF:
- C20H22N2O
- Structure:
- Chemical Name:
- α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile
- CAS:
- 120512-38-1
- MF:
- C14H16N2
- Chemical Name:
- Regorafenib Impurity MJ
- Chemical Name:
- Aztreonam Open-Ring Desulfurization Impurity
- Structure:
- Chemical Name:
- 2-Ethynylaniline
- CAS:
- 52670-38-9
- MF:
- C8H7N
- Chemical Name:
- Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU)
- Structure:
- Chemical Name:
- (2R,3R,4R,5R)-2-(4-amino-2-oxo
- CAS:
- 1415316-72-1
- MF:
- C12H16N4O7
- Structure:
- Chemical Name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol
- MF:
- C21H29NO
- Chemical Name:
- Dexamethasone EP impurities F
- Structure:
- Chemical Name:
- D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)-
- CAS:
- 1355049-94-3
- MF:
- C32H32N4O5
- Chemical Name:
- Delamanid Impurity 1
- Structure:
- Chemical Name:
- N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide
- CAS:
- 1628530-41-5
- MF:
- C28H24FN3O6
- Chemical Name:
- Oseltamivir Impurity Mixture (MW:486 Da)
- Structure:
- Chemical Name:
- (R)-Ethyl 3-(bromomethyl)hexanoate
- CAS:
- 1956435-91-8
- MF:
- C9H17BrO2
- Chemical Name:
- Flucloxacillin Sodium EP Impurity B
- Chemical Name:
- Acyclovir Impurity 15
- Structure:
- Chemical Name:
- Brivaracetam Impurity 5
- CAS:
- 1942054-60-5
- MF:
- C7H13BrO2
- Structure:
- Chemical Name:
- (S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II)
- CAS:
- 1659317-57-3
- MF:
- C33H35CaFN2O4
- Structure:
- Chemical Name:
- Epalrestat Impurity 4
- CAS:
- 130786-32-2
- MF:
- C8H9NO3S2
- Structure:
- Chemical Name:
- Olmesartan Impurity 58
- CAS:
- 2190488-06-1
- MF:
- C12H22N2O2
- Structure:
- Chemical Name:
- Apixaban Impurity 73
- CAS:
- 1998079-13-2
- MF:
- C44H40N8O8
- Structure:
- Chemical Name:
- Alectinib Impurity 10
- CAS:
- 1256584-81-2
- MF:
- C28H29N3O3
- Chemical Name:
- Acemetacin Impurity C
- Chemical Name:
- Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone)
- Chemical Name:
- Vonoprazan Impurity 58
- Chemical Name:
- Tafluprost Impurity 12
- Structure:
- Chemical Name:
- METOPROLOL IMPURITY A
- MF:
- C15H25NO3
- Chemical Name:
- NICERGOLINE IMPURITY A
- Chemical Name:
- L-Cefadroxil Oxide Impurity
- Chemical Name:
- Cefixime Polymer Impurity B
- Chemical Name:
- Azlocillin dioxide Impurity
- Structure:
- Chemical Name:
- Ibrutinib Impurity 42
- CAS:
- 2031255-24-8
- MF:
- C25H23N5O3
- Chemical Name:
- Pramipexole Impurity N
- Structure:
- Chemical Name:
- Hydroxychloroquine Impurity 12 Hydrochloride
- CAS:
- 2411340-31-1
- MF:
- C18H26ClN3O
- Structure:
- Chemical Name:
- Verteporfin impurity
- CAS:
- 121310-58-5
- MF:
- C40H40N4O8
- Chemical Name:
- Peramivir Impurity 25
- Structure:
- Chemical Name:
- Peramivir Impurity 33
- CAS:
- 2758048-78-9
- MF:
- C18H34N2O5
- Chemical Name:
- Imatinib impurity XT
- Structure:
- Chemical Name:
- Verapamil Impurity N
- CAS:
- 2086274-75-9
- MF:
- C33H47N3O4
- Structure:
- Chemical Name:
- Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)-
- CAS:
- 478-83-1
- MF:
- C16H15BrN2O2
- Chemical Name:
- Adefovir Impurity 6
- Chemical Name:
- Apremilast Impurity QY
- Chemical Name:
- Dextrorotation lansoprazole Impurity J
- Chemical Name:
- Dextrorotation lansoprazole-N-oxide
- Chemical Name:
- lansoprazole Impurity 23
- 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
- Structure:
- Chemical Name:
- AZITHROMYCIN IMPURITY B
- CAS:
- 307974-61-4
- MF:
- C38H72N2O11