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:
- Bumetanide iMpurity F
- Structure:
- Chemical Name:
- IODIXANOL RELATED COMPOUND D (50 MG) (5-[ACETYL(2-HYDROXY-3-METHYLPROPYL)AMINO]-N,N'-BIS(2,3-DIHYDROXYPROPYL)2,4,6-TRIIODO-1,3-BENZE-NEDICARBOXAMIDE)
- CAS:
- 89797-00-2
- MF:
- C20H28I3N3O9
- Structure:
- Chemical Name:
- NIMODIPINE RELATED COMPOUND B (50 MG) (BIS(2-METHOXYETHYL) 2,6-DIMETHYL-4-(3-NITROPHE-NYL)-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYLATE) (AS)
- CAS:
- 70172-96-2
- MF:
- C21H26N2O8
- Structure:
- Chemical Name:
- Cefathiamidine Impurity 6
- CAS:
- 28240-16-6
- MF:
- C12H13ClN2O6S
- Structure:
- Chemical Name:
- rac-2,2'-(((3aR,3a'R,4R,4'R,6S,6aS,6'S,6a'S)-((5-nitro-2-(propylthio)pyrimidine-4,6-diyl)bis(azanediyl))bis(2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxole-6,4-diyl))bis(oxy))bis(ethan-1-ol)
- CAS:
- 1882095-50-2
- MF:
- C27H43N5O10S
- Structure:
- Chemical Name:
- Amlodipine Impurity 23 (E-Isomer)
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Axitinib Impurity 12
- Chemical Name:
- Axitinib Impurity 17
- Chemical Name:
- Erlotinib Impurity 37
- Chemical Name:
- Gefitinib impurity M
- Chemical Name:
- Linagliptin Impurity CD10088
- Structure:
- Chemical Name:
- Tacrolimus Ring-opening Impurity
- CAS:
- 1393890-33-9
- MF:
- C44H69NO12
- Structure:
- Chemical Name:
- Tadalafil Impurity 35
- CAS:
- 749864-17-3
- MF:
- C20H18N2O4
- Structure:
- Chemical Name:
- HYDROXYZINE HYDROCHLORIDE
- MF:
- C21H28Cl2N2O2
- Structure:
- Chemical Name:
- Epinastine Impurity 1 HCl
- CAS:
- 141342-71-4
- MF:
- C15H15N3O2
- Structure:
- Chemical Name:
- Flurbiprofen Impurity 5
- CAS:
- 124635-84-3
- MF:
- C18H19FO4
- Structure:
- Chemical Name:
- Azacitidine Impurity 31
- CAS:
- 65024-85-3
- MF:
- C11H16O8
- Structure:
- Chemical Name:
- Diazepam Impurity 3
- CAS:
- 176796-46-6
- MF:
- C17H17ClN2O2
- Structure:
- Chemical Name:
- Pitavastatin Impurity 19 Sodium Salt
- CAS:
- 1980814-87-6
- MF:
- C25H24FNO5
- Structure:
- Chemical Name:
- N-(4-(4-fluorophenyl)-5-((E)-2-((2R,4R)-4-hydroxy-6- oxotetrahydro-2H-pyran-2-yl)vinyl)-6-isopropylpyrimidin- 2-yl)-N-methylmethanesulfonamide
- MF:
- C22H26FN3O5S
- Structure:
- Chemical Name:
- Fulvestrant EP Impurity E
- CAS:
- 2170200-14-1
- MF:
- C32H45F5O3S
- Structure:
- Chemical Name:
- Liquiritigenin-7-O-apiosyl(1-2)-glucoside
- CAS:
- 135432-48-3
- MF:
- C26H30O13
- Chemical Name:
- Edaravone Impurity 16
- Chemical Name:
- Linagliptin Impurity 50
- Structure:
- Chemical Name:
- Landiolol impurity K
- CAS:
- 190601-22-0
- MF:
- C19H29N3O6
- Structure:
- Chemical Name:
- Efinaconazole Impurity 13
- CAS:
- 2055038-61-2
- MF:
- C18H22F2N4O
- Structure:
- Chemical Name:
- Crisaborole Impurity
- CAS:
- 906673-42-5
- MF:
- C14H10BNO3
- Structure:
- Chemical Name:
- tert-butyl 2-((4R,6S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl- 4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate
- CAS:
- 947249-30-1
- MF:
- C40H47FN2O5
- Structure:
- Chemical Name:
- Olanzapine impurity N
- MF:
- C17H20N4S
- Chemical Name:
- Cabozantinib impurity 25
- Chemical Name:
- Afatinib impurity 43
- Chemical Name:
- Vildagliptin Impurity 39
- Chemical Name:
- Tazobactam Impurity D
- Structure:
- Chemical Name:
- Palonosetron Impurity 22
- CAS:
- 1217547-14-2
- MF:
- C19H24N2O2
- Chemical Name:
- Pitavastatin Impurity 35
- Chemical Name:
- Pralatrexate Impurity 15
- Chemical Name:
- Pitavastatin Impurity 52
- Structure:
- Chemical Name:
- Pitavastatin Impurity 60
- CAS:
- 1661064-71-6
- MF:
- C25H22FNO3
- Chemical Name:
- Lenvatinib Impurity 43
- Chemical Name:
- Voriconazole Impurity 10
- Chemical Name:
- Prednicarbate Impurity D
- Structure:
- Chemical Name:
- Olprinone Impurity A
- CAS:
- 141354-29-2
- MF:
- C12H10N4O
- Structure:
- Chemical Name:
- Everolimus EP Impurity E
- CAS:
- 1237826-25-3
- MF:
- C52H79NO14
- Chemical Name:
- Edaravone Impurity P4
- Chemical Name:
- Afatinib impurity 47
- Chemical Name:
- Canagliflozin Impurity 50
- Chemical Name:
- Canagliflozin Impurity 66
- Chemical Name:
- Acyclovir Impurity 12
- Structure:
- Chemical Name:
- 4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile
- MF:
- C14H11NO3
- Chemical Name:
- Cabozantinib impurity P
- Chemical Name:
- Rotigotine Impurity 7
- Chemical Name:
- Nicorandil Impurity B
- Chemical Name:
- Cilastatin Impurity 8
- Structure:
- Chemical Name:
- Tamsulosin impurity E
- MF:
- C20H28N2O5S
- Chemical Name:
- Flucloxacillin Impurity H
- Chemical Name:
- Cefminox Impurity 2
- Chemical Name:
- Afatinib Impurity 56
- Chemical Name:
- Aprepitant Impurity 34
- Chemical Name:
- Bosutinib Impurity 14
- Chemical Name:
- Brivaracetam Impurity 16
- Structure:
- Chemical Name:
- Etoricoxib Impurity 41
- CAS:
- 855307-80-1
- MF:
- C18H13ClN2O2S
- Chemical Name:
- Fluvoxamine Impurity 10
- Structure:
- Chemical Name:
- Nintedanib Impurity 50
- CAS:
- 2410284-90-9
- MF:
- C56H52N8O8
- Chemical Name:
- Olopatadine Impurity 8
- Chemical Name:
- Oseltamivir Impurity 36
- Structure:
- Chemical Name:
- Palbociclib Impurity 61
- CAS:
- 2222404-53-5
- MF:
- C14H20N4O4
- Chemical Name:
- Palbociclib Impurity 41
- Chemical Name:
- Saxagliptin Impurity 8
- Chemical Name:
- Tenofovir Impurity 63
- Chemical Name:
- Ticagrelor Impurity 99
- Chemical Name:
- Ticagrelor Impurity 114
- Chemical Name:
- Ticagrelor Impurity 98
- Chemical Name:
- Tofacitinib Impurity 118
- Chemical Name:
- Trelagliptin Impurity 23
- Chemical Name:
- Vildagliptin Impurity 33
- Chemical Name:
- Vildagliptin Impurity 44
- Structure:
- Chemical Name:
- Voriconazole Impurity 16
- CAS:
- 1157981-64-0
- MF:
- C10H7F2N3O
- Chemical Name:
- Itraconazole iMpurity 3
- Structure:
- Chemical Name:
- 1-(3,5-bis(benzyloxy)phenyl)-2,2-dibromoethan-1-one
- MF:
- C22H18Br2O3
- Chemical Name:
- Axitinib Impurity 8
- Chemical Name:
- Agomelatine Impurity 11
- Chemical Name:
- Saxagliptin Impurity 7
- Chemical Name:
- Cinacalcet Impurity 23
- Chemical Name:
- Erlotinib Impurity 24
- Chemical Name:
- Ticagrelor Impurity 47
- Chemical Name:
- Edaravone Impurity 10
- Chemical Name:
- Empagliflozin Impurity 10
- Chemical Name:
- Canagliflozin Impurity 10
- Chemical Name:
- Rivaroxaban Impurity 35
- Chemical Name:
- Febuxostat Impurity 67
- Structure:
- Chemical Name:
- Hydroxytyrosol 4-O-glucoside
- CAS:
- 54695-80-6
- MF:
- C14H20O8
- Chemical Name:
- Riociguat IMpurtiy A
- Chemical Name:
- Peramivir Impurity C
- Chemical Name:
- Lincomycin sulfoxide Impurity 6
- Chemical Name:
- Metronidazole IMpurity 5
- Chemical Name:
- Sulpiride Impurity 5
- Structure:
- Chemical Name:
- methyl 3-(4-(3-(ethylamino)-2-hydroxypropoxy)phenyl)propanoate hydrochloride
- MF:
- C15H24ClNO4
- Chemical Name:
- Tacrolimus Impurity F
- Chemical Name:
- Cefminox Impurity E
- Structure:
- Chemical Name:
- 2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE
- CAS:
- 102804-82-0
- MF:
- C15H15N3OS