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:
- Piperacillin Impurity N
- Structure:
- Chemical Name:
- 2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate
- CAS:
- 26050-44-2
- MF:
- C10H15NO
- Structure:
- Chemical Name:
- 3,4-DICHLOROBENZYLAMINE HYDROCHLORIDE
- CAS:
- 49552-34-3
- MF:
- C7H8Cl3N
- Structure:
- Chemical Name:
- (S)-3-Methyl-1-(2-piperidin-1-ylphenyl)butylamine
- CAS:
- 147769-93-5
- MF:
- C16H26N2
- Structure:
- Chemical Name:
- 4-(CHLOROMETHYL)BENZYL ALCOHOL 99
- CAS:
- 16473-35-1
- MF:
- C8H9ClO
- Structure:
- Chemical Name:
- 4,4′-DIPHENOQUINONE (DQ)
- CAS:
- 494-72-4
- MF:
- C12H8O2
- Structure:
- Chemical Name:
- ACETYLSIMVASTATIN
- CAS:
- 145576-25-6
- MF:
- C27H40O6
- Structure:
- Chemical Name:
- 5-[2-(4'-METHYLBIPHENYL)]TETRAZOLE
- CAS:
- 120568-11-8
- MF:
- C14H12N4
- Structure:
- Chemical Name:
- L-2-Aminobutanamide
- CAS:
- 7324-11-0
- MF:
- C4H10N2O
- Structure:
- Chemical Name:
- 1H-Imidazole-1-carboxylic acid, (1R)-2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-1-[[[(2R)-3-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-2-[(1H-imidazol-1-ylcarbonyl)oxy]propyl][4-(3-oxo-4-morpholinyl)phenyl]amino]methyl]ethyl ester
- CAS:
- 2097255-05-3
- MF:
- C40H34N8O10
- Chemical Name:
- Elagolix Sodium impurity5
- Chemical Name:
- Tadalafil Impurity 46
- Structure:
- Chemical Name:
- (trans)-4-((2-amino-3,4-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O
- Chemical Name:
- (trans)-3-(4-((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl)butane-1,2,4-triol
- Chemical Name:
- Cefdinir CP Impurity B
- Structure:
- Chemical Name:
- Voriconazole Impurity 15
- CAS:
- 321589-00-8
- MF:
- C22H19F4N7O
- Chemical Name:
- Fluconazole Impurity 2
- Chemical Name:
- Imatinib EP Impurity D Chloride
- Structure:
- Chemical Name:
- Miconazole EP Impurity F
- CAS:
- 47447-55-2
- MF:
- C18H14Cl4N2O
- Structure:
- Chemical Name:
- Raltegravir USP RC E
- CAS:
- 1193687-87-4
- MF:
- C20H22N6O5
- Structure:
- Chemical Name:
- Vigabatrin EP Impurity F
- CAS:
- 794466-81-2
- MF:
- C12H20N2O3
- Structure:
- Chemical Name:
- Dehydronitrosonisoldipine
- CAS:
- 87375-91-5
- MF:
- C20H22N2O5
- Structure:
- Chemical Name:
- Brexpiprazole Impurity 49
- CAS:
- 1700655-67-9
- MF:
- C13H14N2O2S
- Structure:
- Chemical Name:
- Etoricoxib Impurity 38
- CAS:
- 887479-63-2
- MF:
- C13H17NO2S
- Structure:
- Chemical Name:
- Pemetrexed Impurity 19
- CAS:
- 1644286-36-1
- MF:
- C20H21N5O8
- Chemical Name:
- Empagliflozin Impurity 31
- Structure:
- Chemical Name:
- Iguratimod
- CAS:
- 123663-50-3
- MF:
- C18H16N2O6S
- Structure:
- Chemical Name:
- Imidafenacin Related Compound 10
- CAS:
- 212756-27-9
- MF:
- C21H23N3O
- Structure:
- Chemical Name:
- Aprepitant
- CAS:
- 1242175-36-5
- MF:
- C20H18F7NO2
- Structure:
- Chemical Name:
- Idebenone Impurity 5
- CAS:
- 88543-33-3
- MF:
- C18H28O5
- Structure:
- Chemical Name:
- Entacapone Impurity 4
- CAS:
- 1202160-40-4
- MF:
- C11H8N2O6
- Structure:
- Chemical Name:
- L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester
- CAS:
- 1119226-56-0
- MF:
- C30H55NO5
- Structure:
- Chemical Name:
- S-(+)-O-DESMETHYL VENLAFAXINE
- CAS:
- 142761-12-4
- MF:
- C16H25NO2
- Chemical Name:
- cefdinir
- Chemical Name:
- ACICLOVIR, Impurity J
- Structure:
- Chemical Name:
- 1H-Inden-1-amine, 2,3-dihydro-N-2-propen-1-yl-
- CAS:
- 91639-43-9
- MF:
- C12H15N
- Structure:
- Chemical Name:
- Salbutamol impurity 42
- CAS:
- 18910-69-5
- MF:
- C14H23NO3
- Chemical Name:
- (E)-8-(3,4-dimethoxystyryl)
- Structure:
- Chemical Name:
- (+)-Mediresinol Di-O-β-D-glucopyranoside
- CAS:
- 88142-63-6
- MF:
- C33H44O17
- Chemical Name:
- Favipiravir Impurity
- Structure:
- Chemical Name:
- Vildagliptin Dione Impurity
- CAS:
- 1844894-70-7
- MF:
- C17H24N2O3
- Structure:
- Chemical Name:
- Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate
- CAS:
- 1440961-11-4
- MF:
- C22H21FN2O6
- Structure:
- Chemical Name:
- 1H-Pyrrole-3-carboxamide, 5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-N-(2-hydroxyethyl)-2,4-dimethyl-
- CAS:
- 2170562-55-5
- MF:
- C18H18FN3O3
- Structure:
- Chemical Name:
- Apixaban Impurity 70
- CAS:
- 1998079-14-3
- MF:
- C44H40N8O9
- Structure:
- Chemical Name:
- Favipiravir Impurity 14
- CAS:
- 356783-49-8
- MF:
- C5HClFN3
- Structure:
- Chemical Name:
- Posaconazole Impurity 93
- CAS:
- 165115-82-2
- MF:
- C19H19F2IO2
- Chemical Name:
- N-Dealkyl Flurazepam (Midazolam impurity)
- Chemical Name:
- 4-((3-amino-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
- Chemical Name:
- AMIKACIN IMPURITY A
- Structure:
- Chemical Name:
- FUROSEMIDE IMPURITY A
- MF:
- C12H11ClN2O5S
- Chemical Name:
- GLICLAZIDE IMPURITY F
- Structure:
- Chemical Name:
- Itraconazole Impurity 17
- CAS:
- 854372-78-4
- MF:
- C14H15Cl2N3O5S
- Structure:
- Chemical Name:
- sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate
- CAS:
- 53448-45-6
- MF:
- C20H24N2O3
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 35
- CAS:
- 2206360-74-7
- MF:
- C23H24N4O6
- Structure:
- Chemical Name:
- Tirofiban hydrochloride monohydrate Impurity 7
- CAS:
- 2250244-28-9
- MF:
- C13H19NO5S
- Chemical Name:
- Acarbose Impurity G
- Structure:
- Chemical Name:
- Imidafenacin Related Compound 7
- CAS:
- 191592-57-1
- MF:
- C16H13N
- Structure:
- Chemical Name:
- 17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol
- CAS:
- 16669-06-0
- MF:
- C20H25NO2
- Chemical Name:
- Cefaclor Impurity 6
- Structure:
- Chemical Name:
- Cephalexin Impurity 6
- MF:
- C16H17N3O4S
- Chemical Name:
- Pitavastatin Impurity 42
- Structure:
- Chemical Name:
- Rocuronium bromide Impurity J
- MF:
- C32H53BrN2O4
- Chemical Name:
- Tofacitinib Impurity 72
- Chemical Name:
- Tofacitinib Impurity 81
- Structure:
- Chemical Name:
- Topiroxostat Impurity 9
- CAS:
- 2044708-04-3
- MF:
- C7H10N6O
- Chemical Name:
- Vinorelbine EP Impurity C
- Chemical Name:
- Lenvatinib Impurity 35
- Chemical Name:
- Febuxostat Impurity 58
- Chemical Name:
- Cefodizime Impurity B
- Chemical Name:
- Cefodizime Impurity D
- Structure:
- Chemical Name:
- Amlodipine Impurity 49
- CAS:
- 79781-18-3
- MF:
- C18H18ClNO5
- Chemical Name:
- Penicillin Impurity B
- Structure:
- Chemical Name:
- 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)bis[benzoic acid]
- CAS:
- 1644566-39-1
- MF:
- C17H13N3O4
- Chemical Name:
- Cefminox Sodium impurity B
- Chemical Name:
- Cefotiam Impurity B
- Structure:
- Chemical Name:
- pranoprofen impurity 11
- CAS:
- 52549-44-7
- MF:
- C15H13NO4
- Structure:
- Chemical Name:
- Atorvastatin Calcium Hydrate impurity 32
- CAS:
- 2088732-01-6
- MF:
- C14H27NO4
- Chemical Name:
- Cefazolin Impurity 5
- Chemical Name:
- Peramivir Impurity E
- Chemical Name:
- Lincomycin sulfoxide Impurity 3
- Chemical Name:
- Lincomycin sulfoxide Impurity F
- Chemical Name:
- Fasudil iMpurity F
- Structure:
- Chemical Name:
- 1-cyclopropyl-8-ethoxy-6-fluoro-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
- CAS:
- 2252446-70-9
- MF:
- C22H27ClFN3O4
- Chemical Name:
- Doxofylline iMpurity E
- Structure:
- Chemical Name:
- Mupirocin Impurity 3
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Dihydro-Simvastatin
- CAS:
- 92083-03-9
- MF:
- C25H40O5
- Chemical Name:
- Ceftriaxone Sodium impurity 3
- Chemical Name:
- Sugammadex sodium Monoiodo Impurity
- Structure:
- Chemical Name:
- (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine
- MF:
- C20H23NO3
- Structure:
- Chemical Name:
- Avatrombopag Impurity 22
- CAS:
- 570403-14-4
- MF:
- C31H38Cl2N6O3S2
- Structure:
- Chemical Name:
- 176760-99-9
- CAS:
- 176760-99-9
- MF:
- C17H13FN2O4
- Structure:
- Chemical Name:
- NILOTINIB IMPURITY 17
- CAS:
- 851137-91-2
- MF:
- C17H15N5O
- Chemical Name:
- DexMedetoMidine IMpurity 16
- Structure:
- Chemical Name:
- Canagliflozin Impurity 2
- CAS:
- 2952941-15-8
- MF:
- C18H14FIS
- Chemical Name:
- Rivaroxaban Impurity 22
- Structure:
- Chemical Name:
- Levofloxacin Impurity 5
- CAS:
- 2206360-62-3
- MF:
- C13H10FNO5
- Chemical Name:
- Ezetimibe Impurity 33