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:
- 1449029-77-9
- CAS:
- 1449029-77-9
- MF:
- C29H26N4O7
- Structure:
- Chemical Name:
- 295366-48-2
- CAS:
- 295366-48-2
- MF:
- C17H25NO3
- Structure:
- Chemical Name:
- (3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate
- MF:
- C26H25NO5
- Structure:
- Chemical Name:
- Fluticasone Impurity 13
- MF:
- C25H31F3O5S
- Chemical Name:
- nicergoline impurity K
- Structure:
- Chemical Name:
- Clopidogrel Impurity 46
- CAS:
- 1801260-21-8
- MF:
- C25H26ClNO6S
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 89
- CAS:
- 2226413-61-0
- MF:
- C38H46F2N6O9S2
- Structure:
- Chemical Name:
- Ibuprofen EP Impurity I
- CAS:
- 2143535-26-4
- MF:
- C13H18O2
- Chemical Name:
- Moxifloxacin Impurity 11
- Structure:
- Chemical Name:
- Linagliptin Impurity 7
- CAS:
- 2416949-69-2
- MF:
- C25H29N7O4
- Structure:
- Chemical Name:
- Tofacitinib Related Compound 16
- CAS:
- 2183519-70-0
- MF:
- C15H23N5
- Chemical Name:
- Vortioxetine Impurity 8
- Chemical Name:
- Erlotinib Impurity 21
- Structure:
- Chemical Name:
- Fluvastatin EP Impurity C
- CAS:
- 779995-42-5
- MF:
- C24H26FNO4
- Structure:
- Chemical Name:
- Oseltamivir Impurity 17
- CAS:
- 2413185-88-1
- MF:
- C14H22O4
- Chemical Name:
- Topiroxostat Impurity 15
- Chemical Name:
- Teneligliptin Impurity 10 Di-Trifluoroacetate
- Chemical Name:
- Posaconazole iMpurity 68
- Structure:
- Chemical Name:
- CLOPIDOGREL RELATED COMPOUND C (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE, HYDROGEN SUL- FATE)
- CAS:
- 120202-71-3
- MF:
- C16H18ClNO6S2
- Chemical Name:
- Erlotinib Hydrochloride iMpurity 50
- Structure:
- Chemical Name:
- (S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate
- CAS:
- 1213269-49-8
- MF:
- C14H11F2NO4
- Chemical Name:
- Vonoprazan Impurity U3
- Structure:
- Chemical Name:
- Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate
- CAS:
- 137211-63-3
- MF:
- C17H22ClN3O4
- Chemical Name:
- Cefonicid Impurity 1
- Structure:
- Chemical Name:
- 1589503-93-4
- CAS:
- 1589503-93-4
- MF:
- C27H24F2N6O3S
- Structure:
- Chemical Name:
- ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE
- CAS:
- 66338-95-2
- MF:
- C6H8ClNO4
- Structure:
- Chemical Name:
- 2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate
- MF:
- C27H39NO3
- Chemical Name:
- Dexamethasone Impurity EP Impurity C
- Chemical Name:
- Palbociclib impurity LAAP
- Structure:
- Chemical Name:
- (R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide
- MF:
- C15H30N4O3
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 32
- CAS:
- 1528636-07-8
- MF:
- C22H27ClO7
- Structure:
- Chemical Name:
- 1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide)
- MF:
- C28H54N8O2
- Chemical Name:
- N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)-
- Structure:
- Chemical Name:
- Droxidopa Impurity 6
- CAS:
- 90044-46-5
- MF:
- C16H15NO4
- Chemical Name:
- Osimertinib Impurity 2 DiHCl
- Chemical Name:
- Dofetilide Impurity B
- Chemical Name:
- Sugammadex Monohydroxy Impurity
- Chemical Name:
- Cyclic Macitentan quarternary salt Impurity
- Chemical Name:
- Lacosamide Impurity – K
- Chemical Name:
- Cefdinir CP Impurity I&J&K&L
- Chemical Name:
- Dapoxetine Impurity 41
- Chemical Name:
- Doxofylline Impurity 16
- Chemical Name:
- Olopatadine Impurity 5
- CAS:
- 55690-18-1
- MF:
- C17H16O5
- Chemical Name:
- Taladafil Impurity 38
- Chemical Name:
- Salbutamol impurity 41
- Chemical Name:
- Gadobutrol Impurity 20
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 48
- CAS:
- 2069934-29-6
- MF:
- C15H14Cl2O
- Chemical Name:
- Cilostazol Impurity I
- Structure:
- Chemical Name:
- TERBUTALINE IMPURITY C
- CAS:
- 139508-58-0
- MF:
- C12H17NO3
- Chemical Name:
- ZIDOVUDINE IMPURITY B
- Structure:
- Chemical Name:
- (1S,4S,5S)-4-Bromo-6-oxabicyclo[3.2.1]octan-7-one
- CAS:
- 139893-81-5
- MF:
- C7H9BrO2
- Structure:
- Chemical Name:
- Acetamide, N-[2-hydroxy-3-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]propyl]-N-(1-methylethyl)-
- CAS:
- 66722-65-4
- MF:
- C20H33NO5
- Structure:
- Chemical Name:
- Pyrimidine, 4-bromo-6-(1-bromoethyl)-5-fluoro-
- CAS:
- 1307315-02-1
- MF:
- C6H5Br2FN2
- Structure:
- Chemical Name:
- 4-(3,4-dichlorophenyl)-N-methyl-3,4-dihydro-2H-naphthalen-1-imine oxide
- CAS:
- 209473-00-7
- MF:
- C17H15Cl2NO
- Structure:
- Chemical Name:
- 5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one
- CAS:
- 41359-15-3
- MF:
- C9H9N3O6
- Structure:
- Chemical Name:
- Ambrisentan Impurity E
- CAS:
- 1312092-82-2
- MF:
- C21H18N2O3
- Structure:
- Chemical Name:
- 3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
- CAS:
- 153139-56-1
- MF:
- C16H20N2O
- Structure:
- Chemical Name:
- ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5- carboxylate
- CAS:
- 2230270-05-8
- MF:
- C18H20N2O3S
- Chemical Name:
- Cefminox Sodium Impurity 6
- Chemical Name:
- Flurbiprofen Impurity 7
- Structure:
- Chemical Name:
- Imidafenacin Impurity 8
- CAS:
- 503598-05-8
- MF:
- C20H21N3O3
- Structure:
- Chemical Name:
- Pregabalin Impurity E
- CAS:
- 1239692-16-0
- MF:
- C11H24ClNO2
- Chemical Name:
- Rosuvastatin Impurity 86
- Chemical Name:
- Cefathiamidine Impurity 8
- Structure:
- Chemical Name:
- Urapidil impurity 7
- CAS:
- 108997-11-1
- MF:
- C24H34N4O2
- Structure:
- Chemical Name:
- methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate.
- CAS:
- 2089061-92-5
- MF:
- C17H17ClN2O3
- Chemical Name:
- Pregabalin Impurity 15
- Chemical Name:
- Pregabalin Impurity 32
- Structure:
- Chemical Name:
- 4-Hydroxyphthalic Acid
- CAS:
- 501666-22-4
- MF:
- C14H25NO6
- Chemical Name:
- Roxithromycin Impurity K
- Chemical Name:
- Bepotastine N-Oxide Impurity
- Chemical Name:
- Nintedanib Impurity 25
- Chemical Name:
- Tripterygium glycosides
- Structure:
- Chemical Name:
- (RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate
- MF:
- C11H19NO4S
- Chemical Name:
- Linagliptin Impurity 53
- Structure:
- Chemical Name:
- Nintedanib Impurity 52
- CAS:
- 2410284-89-6
- MF:
- C22H30N6O2
- Chemical Name:
- Olaparib Impurity 21
- Chemical Name:
- Oseltamivir Impurity 43
- Chemical Name:
- Osimertinib Impurity 3
- Chemical Name:
- Rosuvastatin Impurity 48
- Structure:
- Chemical Name:
- Sildenafil Impurity 37
- MF:
- C22H30N6O4S
- Chemical Name:
- Sitagliptin Impurity 80
- Chemical Name:
- Teneligliptin Impurity 2
- Chemical Name:
- Ticagrelor Impurity 104
- Chemical Name:
- Ticagrelor Impurity 95
- Chemical Name:
- Tofacitinib Impurity 120
- Chemical Name:
- Vildagliptin Impurity 46
- Chemical Name:
- Carbocistein Impurity C
- Chemical Name:
- (2S,4R)-N-((2S,3S,4S)-1-(((2S,3R)-5-amino-1
- Chemical Name:
- Erythromycin Impurity 4
- Chemical Name:
- Itraconazole iMpurity 5
- Chemical Name:
- Trelagliptin Impurity 15
- Chemical Name:
- Sofosbuvir Impurity 57
- Structure:
- Chemical Name:
- Celecoxib Impurity 6
- MF:
- C17H14F3N3O2S
- Chemical Name:
- Emtricitabine Impurity 6
- Chemical Name:
- Erlotinib Impurity 26
- Chemical Name:
- Fosaprepitant Impurity 5
- Chemical Name:
- Lanthanum test solution(ChP)
- Structure:
- Chemical Name:
- Pramipexole DBTA Impurity
- CAS:
- 1821389-09-6
- MF:
- C7H8N2S
- Chemical Name:
- Amoxicillin Oxidized Impurities