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:
- (1R,3S)-Solifenacin Succinate
- CAS:
- 774517-20-3
- MF:
- C23H26N2O2
- Chemical Name:
- Dacpomycin Impurity 2
- Chemical Name:
- Nicorandil Impurity 3
- Chemical Name:
- Tacrolimus Impurity A
- Structure:
- Chemical Name:
- 1H-Benz[de]isoquinolin-1-one,2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-,(3aR)-
- CAS:
- 135729-73-6
- MF:
- C19H24N2O
- Chemical Name:
- Afatinib Impurity 16
- Chemical Name:
- Mirabegron Impurity 19
- Structure:
- Chemical Name:
- (Z)-Mutagenic Impurity of Tenofovir Disoproxil
- CAS:
- 1464851-21-5
- MF:
- C8H9N5
- Chemical Name:
- Moxifloxacin impurity (20)
- Structure:
- Chemical Name:
- (R)-2-(2-(tert-butoxy)-2-oxoethyl)pentanoic acid
- CAS:
- 112106-16-8
- MF:
- C11H20O4
- Chemical Name:
- Bazedoxifene impurity
- Structure:
- Chemical Name:
- Tamsulosin impurity
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- Clarithromycin (9Z)-Oxime
- CAS:
- 127253-05-8
- MF:
- C38H70N2O13
- Structure:
- Chemical Name:
- N-Desmethyl Clarithromycin (9E)-Oxime
- CAS:
- 127182-43-8
- MF:
- C37H68N2O13
- Structure:
- Chemical Name:
- Ticagrelor Impurity 24
- CAS:
- 1482484-92-3
- MF:
- C7H11N3O2S
- Structure:
- Chemical Name:
- Moxifloxacin Impurity
- CAS:
- 1797982-51-4
- MF:
- C16H16FNO5
- Chemical Name:
- sofosBuvir impurity 1
- Structure:
- Chemical Name:
- 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid
- CAS:
- 144060-52-6
- MF:
- C15H14N2O3S
- Structure:
- Chemical Name:
- Alogliptin Related Compound 26
- CAS:
- 865759-10-0
- MF:
- C25H24N6O2
- Structure:
- Chemical Name:
- R-Tirofiban
- CAS:
- 158808-86-7
- MF:
- C22H36N2O5S
- Chemical Name:
- Canagliflozin Impurity 20
- Chemical Name:
- Canagliflozin Impurity 6
- Chemical Name:
- Carfilzomib Impurity 6
- Structure:
- Chemical Name:
- Daclatasvir Impurity 5 (SRSS-Isomer)
- CAS:
- 1009117-28-5
- MF:
- C40H50N8O6
- Structure:
- Chemical Name:
- Dolutegravir Impurity 7
- CAS:
- 2244161-71-3
- MF:
- C20H21N3O5
- Chemical Name:
- Istradefylline Impurity F
- Chemical Name:
- Linagliptin Impurity 22
- Structure:
- Chemical Name:
- Nintedanib impurity G
- CAS:
- 894783-61-0
- MF:
- C30H31N5O4
- Structure:
- Chemical Name:
- 3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine)
- CAS:
- 1010818-93-5
- MF:
- C27H34N2O2
- Structure:
- Chemical Name:
- Febuxostat impurity 36
- CAS:
- 1805770-40-4
- MF:
- C12H12N2O
- Structure:
- Chemical Name:
- N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide
- CAS:
- 2031255-27-1
- MF:
- C28H26N6O3
- Structure:
- Chemical Name:
- 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
- MF:
- C8H11FN3O4S-
- Chemical Name:
- Anastrozole Impurity 3
- Structure:
- Chemical Name:
- Cephalexin Impurity 4
- MF:
- C16H17N3O4S
- Chemical Name:
- Rivaroxaban Impurity 42
- Structure:
- Chemical Name:
- (R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid
- CAS:
- 1422514-05-3
- MF:
- C22H26FN3O6S
- Structure:
- Chemical Name:
- Atorvastatin 2-Fluoro t-Butyl Ester
- CAS:
- 1099474-28-8
- MF:
- C40H47FN2O5
- Chemical Name:
- Cabozantinib Impurity C
- Structure:
- Chemical Name:
- (3R,4R)-N,4-dimethyl-piperidin-3-amine
- CAS:
- 1354469-76-3
- MF:
- C7H16N2
- Structure:
- Chemical Name:
- 4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine
- CAS:
- 952518-97-7
- MF:
- C9H7N5
- Structure:
- Chemical Name:
- 5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde
- CAS:
- 881676-90-0
- MF:
- C16H12N2O3S
- Structure:
- Chemical Name:
- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-
- CAS:
- 100332-12-5
- MF:
- C13H18FNO
- Structure:
- Chemical Name:
- r-Cytidine
- CAS:
- 13913-16-1
- MF:
- C9H13N3O5
- Structure:
- Chemical Name:
- Pyridine, 4-chloro-2-(chloromethyl)-3-methyl-
- CAS:
- 168167-48-4
- MF:
- C7H7Cl2N
- Structure:
- Chemical Name:
- Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride
- CAS:
- 71784-27-5
- MF:
- C35H41ClN4O6
- Structure:
- Chemical Name:
- 3-amino-6-chloro-2-methyl-4-phenylquinazolin-4-ol
- CAS:
- 27537-87-7
- MF:
- C15H14ClN3O
- Structure:
- Chemical Name:
- Riluzole 5-Trifluoromethoxy Isomer
- CAS:
- 752969-85-0
- MF:
- C8H5F3N2OS
- Structure:
- Chemical Name:
- Pazufloxacin Impurity 7
- CAS:
- 171567-48-9
- MF:
- C15H15FN2O3
- Chemical Name:
- Empagliflozin Impurity 42
- Structure:
- Chemical Name:
- 2-amino-2-(4-nonylphenethyl)propane-1,3-diol
- CAS:
- 746594-44-5
- MF:
- C20H35NO2
- Chemical Name:
- Zopiclone Impurity 17
- Structure:
- Chemical Name:
- Pregabalin Impurity D
- CAS:
- 53439-96-6
- MF:
- C11H14O3
- Structure:
- Chemical Name:
- Cephalosporin Impurity 3 HCl
- CAS:
- 2429-86-9
- MF:
- C14H17N3O6S
- Structure:
- Chemical Name:
- ((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl) methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro- 2H-pyran-2-yl)methyl acetate
- CAS:
- 2146135-87-5
- MF:
- C26H27FO6S
- Chemical Name:
- Atracurium Impurity 5
- Chemical Name:
- Cefazolin Impurity 1
- Structure:
- Chemical Name:
- Tofacitinib Impurity 77
- CAS:
- 1640971-51-2
- MF:
- C16H20N6O2
- Chemical Name:
- Tofacitinib Impurity 84
- Structure:
- Chemical Name:
- De(carboxymethoxy) Cetirizine Acetic Acid Dihydrochloride
- CAS:
- 1000690-91-4
- MF:
- C19H22Cl2N2O2
- Structure:
- Chemical Name:
- 7-Despropyl 7-Methyl Vardenafil
- CAS:
- 2169247-39-4
- MF:
- C21H28N6O4S
- Chemical Name:
- Apixaban Impurity 32
- Chemical Name:
- Apremilast Impurity 20
- Chemical Name:
- Bendamustine Impurity 36
- Structure:
- Chemical Name:
- Bosutinib Impurity 7
- CAS:
- 219786-51-3
- MF:
- C10H12BrNO4
- Chemical Name:
- Cefazolin Impurity 13
- Chemical Name:
- Cefoxitin Impurity 4
- Structure:
- Chemical Name:
- Cilnidipine Impurity 3
- CAS:
- 123853-41-8
- MF:
- C24H22N2O6
- Chemical Name:
- Erlotinib Impurity 50
- Chemical Name:
- Pitavastatin Impurity 26
- Chemical Name:
- Plerixafor Impurity 2
- Structure:
- Chemical Name:
- Pregabalin Impurity 48
- CAS:
- 1239856-83-7
- MF:
- C11H23NO2
- Chemical Name:
- Rivaroxaban Impurity 76
- Chemical Name:
- Rocuronium bromide Impurity 36
- Structure:
- Chemical Name:
- Sildenafil Impurity 14
- CAS:
- 2146091-79-2
- MF:
- C24H32N6OS2
- Structure:
- Chemical Name:
- Telmisartan Impurity 6
- CAS:
- 1083158-65-9
- MF:
- C19H22N4O
- Chemical Name:
- Apremilast Impurity CNA
- Chemical Name:
- Atracurium Impurity Q
- Chemical Name:
- Atracurium Impurity W
- Chemical Name:
- AZD9291(Osimertinib) Impurity 5
- Chemical Name:
- Azilsartan impurity Y
- Structure:
- Chemical Name:
- Celecoxib Impurity 15
- MF:
- C17H14F3N3O2S
- Chemical Name:
- Etoposide Impurity 2
- Chemical Name:
- Fludarabine EP impurity J
- Chemical Name:
- Ropivacaine Impurity 12
- Structure:
- Chemical Name:
- Solifenacin impurity 17
- CAS:
- 1029430-94-1
- MF:
- C19H17N3O
- Chemical Name:
- Sugammadex sodium Org205485-1 Impurity
- Chemical Name:
- Sugammadex sodium Org246653-1 Impurity
- Chemical Name:
- Tadalafil impurity R
- Structure:
- Chemical Name:
- N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide
- CAS:
- 198471-47-5
- MF:
- C19H16F3N3O3S
- Chemical Name:
- Afatinib impurity 35
- Structure:
- Chemical Name:
- Avibactam Impurity 40
- CAS:
- 2089462-89-3
- MF:
- C15H20N2O3
- Chemical Name:
- Butyphthalide impurity 29
- Structure:
- Chemical Name:
- Butyphthalide impurity 38
- CAS:
- 1841089-56-2
- MF:
- C24H30O5
- Chemical Name:
- Canagliflozin Impurity 39
- Chemical Name:
- Cefaclor double bond displacement impurity 9
- Chemical Name:
- Diquafosol Impurity 7
- Chemical Name:
- Febuxostat Impurity 75
- Chemical Name:
- Febuxostat Impurity 90
- CAS:
- 2646683-37-4
- Chemical Name:
- Febuxostat Impurity 95
- Structure:
- Chemical Name:
- Ibrutinib Impurity 17
- CAS:
- 2134109-10-5
- MF:
- C16H18N6O