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:
- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro-
- CAS:
- 1648791-23-4
- MF:
- C29H43N5
- Chemical Name:
- Linagliptin Impurity O
- Chemical Name:
- Linagliptin Impurity T
- Structure:
- Chemical Name:
- (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide
- MF:
- C18H22FN5O3
- Chemical Name:
- Apremilast Impurity 2
- Chemical Name:
- Etoricoxib Impurity 16
- Chemical Name:
- Ibrutinib Impurity 2
- Chemical Name:
- Mirabegron Impurity 14
- Structure:
- Chemical Name:
- Vonoprazan Impurity 1
- CAS:
- 881732-90-7
- MF:
- C17H17N3O2S
- Structure:
- Chemical Name:
- Atenolol EP Impurity
- MF:
- C14H22N2O3
- Chemical Name:
- Cinacalcet Impurity 20
- Chemical Name:
- Dapagliflozin Impurity 11
- Chemical Name:
- Dasatinib Impurity C
- Structure:
- Chemical Name:
- Etoricoxib impurity Q
- CAS:
- 292067-97-1
- MF:
- C18H15ClN2S
- Chemical Name:
- Flucloxacillin Impurity
- Structure:
- Chemical Name:
- Fluorometholone Impurity
- CAS:
- 2796-99-8
- MF:
- C23H31FO7S
- Structure:
- Chemical Name:
- Verapamil Impurity
- CAS:
- 1551304-28-9
- MF:
- C12H19NO2
- Structure:
- Chemical Name:
- Clopidogrel impurity reference substance
- MF:
- C15H14ClNO2S
- Chemical Name:
- Vildagliptin Impurity
- Chemical Name:
- Aloeemodin-ω-O-β-D-glucopyranoside
- CAS:
- 29010-56-8
- MF:
- C21H20O10
- Structure:
- Chemical Name:
- ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
- CAS:
- 2029205-62-5
- MF:
- C26H25ClN4O4
- Structure:
- Chemical Name:
- 1-Butanaminium, N,N,N-tributyl-, (1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl sulfate
- CAS:
- 1192651-80-1
- MF:
- C23H46N4O6S
- Chemical Name:
- Dihydroxyoxaliplatin(Oxaliplatin Impurity Ⅲ)
- Chemical Name:
- cefditoren E-isomer(C=C)
- Chemical Name:
- Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ
- Structure:
- Chemical Name:
- 2-Ethoxybenzimidohydrazide
- CAS:
- 889943-46-8
- MF:
- C9H13N3O
- Structure:
- Chemical Name:
- (41S,12S,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-carboxylic acid
- CAS:
- 59413-21-7
- MF:
- C20H25N2NaO3
- Structure:
- Chemical Name:
- BDJS-SH 1
- CAS:
- 36588-45-1
- MF:
- C12H18N2O2
- Chemical Name:
- Acyclovir Impurity O
- Chemical Name:
- Alogliptin Impurity 19
- Structure:
- Chemical Name:
- Aprepitant Impurity 17
- CAS:
- 1333998-27-8
- MF:
- C20H19ClF7NO2
- Chemical Name:
- Blonanserin impurity A
- Chemical Name:
- Captopril impurity 2
- Structure:
- Chemical Name:
- Ciprofloxacin Impurity D HCl
- CAS:
- 526204-10-4
- MF:
- C17H18FN3O3
- Chemical Name:
- Clindamycin Impurity 6
- Chemical Name:
- Dabigatran Impurity 5
- Chemical Name:
- DecitaBine Impurity 10
- Structure:
- Chemical Name:
- Empagliflozin Impurity 17
- CAS:
- 2452301-27-6
- MF:
- C23H28O7
- Chemical Name:
- Erlotinib Impurity 31
- Chemical Name:
- Everolimus impurity C
- Chemical Name:
- Ezetimibe Impurity 28
- Chemical Name:
- FeBuxostat Impurity 30
- Structure:
- Chemical Name:
- Fluconazole Impurity 5
- CAS:
- 94952-36-0
- MF:
- C13H12F2N6O
- Chemical Name:
- Fosaprepitant Impurity 2
- Structure:
- Chemical Name:
- Imidafenacin Impurity 4
- CAS:
- 503598-78-5
- MF:
- C16H18N2O
- Chemical Name:
- Intedanib Impurity H
- Chemical Name:
- Isavuconazole Impurity 16
- Chemical Name:
- Isavuconazole Impurity 4
- Structure:
- Chemical Name:
- Lenvatinib Impurity 4
- MF:
- C28H22ClN5O5
- Chemical Name:
- Linagliptin Impurity 45
- Chemical Name:
- MiraBegron Impurity F
- Chemical Name:
- Moxifloxacin Impurity 19
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 34
- CAS:
- 1824286-08-9
- MF:
- C9H7ClF2O3
- Structure:
- Chemical Name:
- Nifedipine Impurity J
- CAS:
- 114709-68-1
- MF:
- C16H17N3O5
- Structure:
- Chemical Name:
- 3-((3S,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanenitrile
- CAS:
- 1092578-48-7
- MF:
- C16H20N6O
- Structure:
- Chemical Name:
- 4-aMino-5-chloro-2,3-dihydro-N-4-piperidinyl-7-BenzofurancarboxaMide
- CAS:
- 137211-64-4
- MF:
- C14H18ClN3O2
- Structure:
- Chemical Name:
- 2-[3-Carboxy-4-(2-Methylpropoxy)phenyl]-4-Methyl-5-thiazolecarboxylic Acid
- CAS:
- 1239233-87-4
- MF:
- C16H17NO5S
- Structure:
- Chemical Name:
- 4-(2-Methylpropyl)benzeneethanol
- CAS:
- 36039-35-7
- MF:
- C12H18O
- Structure:
- Chemical Name:
- Dasatinib DiMeric IMpurity
- CAS:
- 910297-61-9
- MF:
- C36H34Cl2N12O2S2
- Structure:
- Chemical Name:
- Decarboxy Fexofenadine
- CAS:
- 185066-37-9
- MF:
- C31H39NO2
- Structure:
- Chemical Name:
- (2R,3R,4R,5R)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-chloro-4-Methyltetrahydrofuran-3-yl benzoate
- CAS:
- 1496551-70-2
- MF:
- C31H26ClN3O7
- Structure:
- Chemical Name:
- 1-((2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione
- CAS:
- 114262-49-6
- MF:
- C10H14N2O6
- Structure:
- Chemical Name:
- 4-(4-(3-(4-chloro-3-(trifluoroMethyl)phenyl)ureido)-3-fluorophenoxy)-2-(MethylcarbaMoyl)pyridine 1-oxide
- CAS:
- 835621-11-9
- MF:
- C21H15ClF4N4O4
- Structure:
- Chemical Name:
- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-(1-ethylpropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]Methyl]-1-(1H-1,2,4-triazol-1-yl)-
- CAS:
- 161532-65-6
- MF:
- C37H42F2N8O3
- Structure:
- Chemical Name:
- Oxiracetam Impurity I
- CAS:
- 142274-07-5
- MF:
- C7H9NO4
- Chemical Name:
- PalBociclib Impurity 4
- Chemical Name:
- Plerixafor Impurity 4
- Chemical Name:
- Posaconazole Impurity 29
- Chemical Name:
- Posaconazole Impurity 34
- Chemical Name:
- Posaconazole Impurity 58
- Structure:
- Chemical Name:
- Pregabalin Impurity 4
- CAS:
- 1955498-14-2
- MF:
- C10H22ClNO2
- Chemical Name:
- Rabeprazole Impurity 17
- Chemical Name:
- SofosBuvir Impurity 14
- Chemical Name:
- sofosBuvir Impurity 34
- Chemical Name:
- SofosBuvir Impurity 50
- Chemical Name:
- SofosBuvir Impurity 56
- Structure:
- Chemical Name:
- Tofacitinib impurity T
- CAS:
- 1092578-43-2
- MF:
- C16H20N6O
- Structure:
- Chemical Name:
- Valsartan Impurity 39
- MF:
- C24H29N5O3
- Structure:
- Chemical Name:
- Donepezil Impurity
- CAS:
- 844694-84-4
- MF:
- C24H31NO2
- Structure:
- Chemical Name:
- imp.E
- CAS:
- 950781-89-2
- MF:
- C13H12F3N3O3
- Structure:
- Chemical Name:
- Lidocaine EP Impurity
- CAS:
- 31785-64-5
- MF:
- C12H18N2O.ClH
- Structure:
- Chemical Name:
- Prucalopride Impurity 1
- CAS:
- 1900715-96-9
- MF:
- C18H24ClN3O3
- Structure:
- Chemical Name:
- 3-(5-CHLOROPYRID-2-YL)CARBAMOYLPYRAZINE-2-CARBOXYLIC ACID(WXG01564)
- CAS:
- 43200-83-5
- MF:
- C11H7ClN4O3
- Chemical Name:
- Ampicillin Impurity Q
- Chemical Name:
- Cefdinir Impurity PQ(CP)
- Chemical Name:
- Cefdinir Impurity IJKL
- Chemical Name:
- Ceftazidime Impurity A (EP)
- Chemical Name:
- Oxacillin Sodium Impurity E(EP)
- Chemical Name:
- Spectinomycin Impurity B
- Structure:
- Chemical Name:
- Eriodictyol-8-glucoside
- CAS:
- 153733-96-1
- MF:
- C21H22O11
- Structure:
- Chemical Name:
- Naringin 4'-glucoside
- CAS:
- 17257-21-5
- MF:
- C33H42O19
- Structure:
- Chemical Name:
- 8-(benzo[b]thiophen-4-yl)-5,8-diazaspiro[4.5]decan-5-ium chloride
- CAS:
- 2143944-64-1
- MF:
- C16H21N2S+
- Structure:
- Chemical Name:
- 2-(4'-chloro-2,3,4,5-tetrahydro-[1,1'-biphenyl]-4-yl)-3-hydroxynaphthalene-1,4-dione
- CAS:
- 1809464-27-4
- MF:
- C22H17ClO3
- Chemical Name:
- Aprepitant impurity C
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 14
- CAS:
- 2056269-94-2
- MF:
- C23H28F2N6O4S
- Structure:
- Chemical Name:
- Cefoxitin impurity E
- CAS:
- 2395025-32-6
- MF:
- C17H19N3O8S2
- Structure:
- Chemical Name:
- N-((4-(3-methyl-5-phenylisoxazol-4-yl)phenyl)sulfonyl)propionamide
- CAS:
- 477594-28-8
- MF:
- C19H18N2O4S
- Chemical Name:
- Moxifloxacin EP Impurity D HCl
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 30
- CAS:
- 1395056-42-4
- MF:
- C21H24FN3O7
- Structure:
- Chemical Name:
- Tenofovir Impurity 37
- CAS:
- 161760-03-8
- MF:
- C10H15O6PS