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.
- Chemical Name:Bendamustine Impurity 36
- CAS:
- MF:
- Structure:
- Chemical Name:Bosutinib Impurity 7
- CAS:219786-51-3
- MF:C10H12BrNO4
- Chemical Name:Cefazolin Impurity 13
- CAS:
- MF:
- Chemical Name:Cefoxitin Impurity 4
- CAS:
- MF:
- Structure:
- Chemical Name:Cilnidipine Impurity 3
- CAS:123853-41-8
- MF:C24H22N2O6
- Chemical Name:Erlotinib Impurity 50
- CAS:
- MF:
- Chemical Name:Pitavastatin Impurity 26
- CAS:
- MF:
- Chemical Name:Plerixafor Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:Pregabalin Impurity 48
- CAS:1239856-83-7
- MF:C11H23NO2
- Chemical Name:Rivaroxaban Impurity 76
- CAS:
- MF:
- Chemical Name:Rocuronium bromide Impurity 36
- CAS:
- MF:
- 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
- CAS:
- MF:
- Chemical Name:Atracurium Impurity Q
- CAS:
- MF:
- Chemical Name:Atracurium Impurity W
- CAS:
- MF:
- Chemical Name:AZD9291(Osimertinib) Impurity 5
- CAS:
- MF:
- Chemical Name:Azilsartan impurity Y
- CAS:
- MF:
- Structure:
- Chemical Name:Celecoxib Impurity 15
- CAS:
- MF:C17H14F3N3O2S
- Chemical Name:Etoposide Impurity 2
- CAS:
- MF:
- Chemical Name:Fludarabine EP impurity J
- CAS:
- MF:
- Chemical Name:Ropivacaine Impurity 12
- CAS:
- MF:
- Structure:
- Chemical Name:Solifenacin impurity 17
- CAS:1029430-94-1
- MF:C19H17N3O
- Chemical Name:Sugammadex sodium Org205485-1 Impurity
- CAS:
- MF:
- Chemical Name:Sugammadex sodium Org246653-1 Impurity
- CAS:
- MF:
- Chemical Name:Tadalafil impurity R
- CAS:
- MF:
- 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
- CAS:
- MF:
- Structure:
- Chemical Name:Avibactam Impurity 40
- CAS:2089462-89-3
- MF:C15H20N2O3
- Chemical Name:Butyphthalide impurity 29
- CAS:
- MF:
- Structure:
- Chemical Name:Butyphthalide impurity 38
- CAS:1841089-56-2
- MF:C24H30O5
- Chemical Name:Canagliflozin Impurity 39
- CAS:
- MF:
- Chemical Name:Cefaclor double bond displacement impurity 9
- CAS:
- MF:
- Chemical Name:Diquafosol Impurity 7
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 75
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 90
- CAS:2646683-37-4
- MF:
- Chemical Name:Febuxostat Impurity 95
- CAS:
- MF:
- Structure:
- Chemical Name:Ibrutinib Impurity 17
- CAS:2134109-10-5
- MF:C16H18N6O
- Chemical Name:LCZ696(valsartan + sacubitril) impurity 36
- CAS:
- MF:
- Chemical Name:Lenvatinib Impurity 17
- CAS:
- MF:
- Chemical Name:Moxifloxacin degradation impurity 36
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 49
- CAS:
- MF:
- Chemical Name:Olsalazine Impurity B
- CAS:
- MF:
- Chemical Name:Parecoxib sodium Impurity 32
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 39
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 95
- CAS:
- MF:
- Chemical Name:Vildagliptin Impurity ZA4
- CAS:
- MF:
- Structure:
- Chemical Name:(E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide
- CAS:
- MF:C15H17N3O2S
- 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
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity 50
- CAS:
- MF:
- 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
- CAS:
- MF:C17H20N4S
- Chemical Name:Cabozantinib impurity 25
- CAS:
- MF:
- Chemical Name:Afatinib impurity 43
- CAS:
- MF:
- Chemical Name:Vildagliptin Impurity 39
- CAS:
- MF:
- Chemical Name:Tazobactam Impurity D
- CAS:
- MF:
- Structure:
- Chemical Name:Palonosetron Impurity 22
- CAS:1217547-14-2
- MF:C19H24N2O2
- Chemical Name:Pitavastatin Impurity 35
- CAS:
- MF:
- Chemical Name:Pralatrexate Impurity 15
- CAS:
- MF:
- Chemical Name:Pitavastatin Impurity 52
- CAS:
- MF:
- Structure:
- Chemical Name:Pitavastatin Impurity 60
- CAS:1661064-71-6
- MF:C25H22FNO3
- Chemical Name:Lenvatinib Impurity 43
- CAS:
- MF:
- Chemical Name:Voriconazole Impurity 10
- CAS:
- MF:
- Chemical Name:Prednicarbate Impurity D
- CAS:
- MF:
- 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
- CAS:
- MF:
- Chemical Name:Afatinib impurity 47
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 50
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 66
- CAS:
- MF:
- Chemical Name:Acyclovir Impurity 12
- CAS:
- MF:
- Structure:
- Chemical Name:4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile
- CAS:
- MF:C14H11NO3
- Chemical Name:Cabozantinib impurity P
- CAS:
- MF:
- Chemical Name:Rotigotine Impurity 7
- CAS:
- MF:
- Chemical Name:Nicorandil Impurity B
- CAS:
- MF:
- Chemical Name:Cilastatin Impurity 8
- CAS:
- MF:
- Structure:
- Chemical Name:Tamsulosin impurity E
- CAS:
- MF:C20H28N2O5S
- Chemical Name:Flucloxacillin Impurity H
- CAS:
- MF:
- Chemical Name:Cefminox Impurity 2
- CAS:
- MF:
- Chemical Name:Afatinib Impurity 56
- CAS:
- MF:
- Chemical Name:Aprepitant Impurity 34
- CAS:
- MF:
- Chemical Name:Bosutinib Impurity 14
- CAS:
- MF:
- Chemical Name:Brivaracetam Impurity 16
- CAS:
- MF:
- Structure:
- Chemical Name:Etoricoxib Impurity 41
- CAS:855307-80-1
- MF:C18H13ClN2O2S
- Chemical Name:Fluvoxamine Impurity 10
- CAS:
- MF:
- Structure:
- Chemical Name:Nintedanib Impurity 50
- CAS:2410284-90-9
- MF:C56H52N8O8
- Chemical Name:Olopatadine Impurity 8
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 36
- CAS:
- MF:
- Structure:
- Chemical Name:Palbociclib Impurity 61
- CAS:2222404-53-5
- MF:C14H20N4O4
- Chemical Name:Palbociclib Impurity 41
- CAS:
- MF:
- Chemical Name:Saxagliptin Impurity 8
- CAS:
- MF:
- Chemical Name:Tenofovir Impurity 63
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 99
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 114
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 98
- CAS:
- MF: