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:
- Rosuvastatin Impurity 47
- Structure:
- Chemical Name:
- Sildenafil Impurity 36
- MF:
- C25H27N3O5
- Chemical Name:
- Sunitinib Impurity 4
- Chemical Name:
- Tafluprost Impurity 11
- Chemical Name:
- Tazobactam Impurity 4
- Chemical Name:
- Ticagrelor Impurity 103
- Chemical Name:
- Ticagrelor Impurity 94
- Chemical Name:
- Tofacitinib Impurity 119
- Chemical Name:
- Trelagliptin Impurity 26
- Chemical Name:
- Trelagliptin Impurity 31
- Chemical Name:
- Caspofungin impurity E
- Chemical Name:
- Erythromycin Impurity C
- Chemical Name:
- Itraconazole iMpurity 4
- Chemical Name:
- Azacitidine Impurity 3
- Chemical Name:
- Ozagrel Impurity 2
- Chemical Name:
- Olaparib Impurity 22
- Structure:
- Chemical Name:
- Irbesartan Impurity 14
- CAS:
- 133690-91-2
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- Febuxostat Impurity 25
- CAS:
- 1643131-89-8
- MF:
- C17H20N2O4S
- Structure:
- Chemical Name:
- 3-Oxo Atorvastatin tert-Butyl Ester
- CAS:
- 134394-98-2
- MF:
- C37H41FN2O5
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(4-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- MF:
- C23H29FN6O4S
- Structure:
- Chemical Name:
- (5-Ethyl-1H-imidazol-4-yl)methanol
- CAS:
- 38603-74-6
- MF:
- C6H10N2O
- Structure:
- Chemical Name:
- (Z)-1-(6-methylpyridin-3-yl)-2-(4-(methylsulfonyl)phenyl)ethanone oxime
- CAS:
- 1810761-43-3
- MF:
- C15H16N2O3S
- Structure:
- Chemical Name:
- tert-butyl 2-((4R,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate
- MF:
- C14H27NO4
- Chemical Name:
- Apixaban Impurity A
- Structure:
- Chemical Name:
- ethylidene phthalide
- CAS:
- 61658-90-0
- MF:
- C10H8O2
- Structure:
- Chemical Name:
- 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl) -7-methyl-7,9-dihydro-8H-purin-8-one
- CAS:
- 1361569-18-7
- MF:
- C19H15FN8O
- Structure:
- Chemical Name:
- 5-(TRIFLUOROMETHYL)-3-P-TOLYL-1H-PYRAZOLE
- CAS:
- 219986-64-8
- MF:
- C11H9F3N2
- Structure:
- Chemical Name:
- Lucidin 3-O-glucoside
- CAS:
- 22255-29-4
- MF:
- C21H20O10
- Chemical Name:
- Bendamustine Impurity 26
- Chemical Name:
- Canagliflozin Impurity 26
- Structure:
- Chemical Name:
- Edoxaban Impurity 37
- CAS:
- 2081883-50-1
- MF:
- C14H27N3O3
- Chemical Name:
- Imatinib Impurity 10
- Structure:
- Chemical Name:
- Levofloxacin Impurity 19
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- Olanzapine Impurity K
- MF:
- C17H20N4S
- Chemical Name:
- Ticagrelor Related Compound 55
- Chemical Name:
- Ticagrelor Related Compound 73
- Chemical Name:
- Vildagliptin Impurity 10
- Structure:
- Chemical Name:
- Pregabalin Impurity 3
- CAS:
- 1928754-83-9
- MF:
- C12H22O3
- Chemical Name:
- Bosutinib Impurity 6
- Chemical Name:
- Ticagrelor Impurity 49
- CAS:
- 2376278-80-5
- Chemical Name:
- Edoxaban Impurity 14
- Structure:
- Chemical Name:
- Indacaterol Impurity 3
- CAS:
- 2250243-41-3
- MF:
- C26H32N2O3
- Chemical Name:
- Canagliflozin Impurity 11
- Chemical Name:
- Oseltamivir Impurity 22
- Chemical Name:
- Riociguat IMpurtiy B
- Structure:
- Chemical Name:
- Amlodipine Impurity 48
- CAS:
- 39562-06-6
- MF:
- C18H20ClNO4
- Chemical Name:
- Silodosin Impurity C
- Structure:
- Chemical Name:
- Dexmedetomidine-025
- CAS:
- 2250242-52-3
- MF:
- C20H22N2
- Chemical Name:
- pranoprofen impurity 15
- Structure:
- Chemical Name:
- Mono-Hydroxy Sugammadex
- CAS:
- 2376607-99-5
- MF:
- C69H109NaO47S7
- Chemical Name:
- Metronidazole impurity A
- Chemical Name:
- Sulpiride Impurity 6
- Chemical Name:
- Cefminox Impurity A
- Chemical Name:
- Cefminox Impurity F
- Structure:
- Chemical Name:
- 5-Methyl-3-phenylisoxazole-4-carboxylic acid
- CAS:
- 1136-45-4
- MF:
- C11H9NO3
- Structure:
- Chemical Name:
- Cefaclor Impurity 2
- CAS:
- 722547-49-1
- MF:
- C17H18N2O3
- Chemical Name:
- Cefodizime Impurity F
- Chemical Name:
- Olaparib Impurity F
- Chemical Name:
- Ornidazole Impurity G
- Chemical Name:
- Pidotimod Impurity L
- Chemical Name:
- Tadalafil Impuirty 20
- CAS:
- 2924098-58-6
- Chemical Name:
- Tenofovir Impurity 53
- Structure:
- Chemical Name:
- (S)-3-(4-benzylphenoxy)tetrahydrofuran
- MF:
- C17H18O2
- Structure:
- Chemical Name:
- Ampicillin
- CAS:
- 1207726-28-0
- MF:
- C24H26N4O5S
- Structure:
- Chemical Name:
- ethyl 2-(4-(sec-butoxy)-3-cyanophenyl)-4-methylthiazole-5- carboxylate
- CAS:
- 2375033-35-3
- MF:
- C18H20N2O3S
- Structure:
- Chemical Name:
- (S)-Indacaterol
- CAS:
- 1384188-70-8
- MF:
- C24H29ClN2O3
- Structure:
- Chemical Name:
- Aripiprazole Impurity 47
- CAS:
- 2250242-47-6
- MF:
- C27H33Cl2N3O3
- Structure:
- Chemical Name:
- Cefminox Sodium Impurity 3
- CAS:
- 1420072-83-8
- MF:
- C16H21N7O6S4
- Chemical Name:
- Edaravone Impurity 26
- CAS:
- 152494-76-3
- Structure:
- Chemical Name:
- Levofloxacin Impurity 24
- MF:
- C18H20FN3O4
- Chemical Name:
- Parecoxib N-Oxide
- Chemical Name:
- Rosuvastatin Impurity 84
- Chemical Name:
- Timolol EP Impurity I
- Structure:
- Chemical Name:
- 172967-64-5
- CAS:
- 172967-64-5
- MF:
- C18H16ClNO3
- Structure:
- Chemical Name:
- Pregabalin Impurity PD0224377
- CAS:
- 501665-97-0
- MF:
- C14H25NO6
- Chemical Name:
- Nintedanib Impurity 24
- Structure:
- Chemical Name:
- 2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-1H-benzo[d] imidazol-5-ol
- CAS:
- 1166386-02-2
- MF:
- C15H15N3O3S
- Structure:
- Chemical Name:
- N-((2-(5-methyl-4-phenylisoxazol-3-yl)phenyl)sulfonyl)propionamide
- CAS:
- 2304623-38-7
- MF:
- C19H18N2O4S
- Chemical Name:
- Cefminox Impurity 1
- Structure:
- Chemical Name:
- Amlodipine Impurity 25
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Axitinib Impurity 13
- Chemical Name:
- Axitinib Impurity 18
- Chemical Name:
- Erlotinib Impurity 38
- Chemical Name:
- Etoricoxib Impurity 31
- Chemical Name:
- Nicorandil Impurity 6
- Structure:
- Chemical Name:
- VIOLURIC ACID
- CAS:
- 87-39-8
- MF:
- C4H3N3O4
- Chemical Name:
- Atracurium Impurity R
- Chemical Name:
- Fludarabine EP impurity K
- Chemical Name:
- Ropivacaine Impurity 28
- Chemical Name:
- Ropivacaine Impurity 6
- Chemical Name:
- Solifenacin ring opening Impurity 11
- Chemical Name:
- Sugammadex sodium Org210839-1 Impurity
- Chemical Name:
- Sugammadex sodium Org284426-1 Impurity
- Chemical Name:
- Bendamustine Related Impurity 6
- Structure:
- Chemical Name:
- Butyphthalide impurity 39
- CAS:
- 1841089-57-3
- MF:
- C24H28O4
- Chemical Name:
- Butyphthalide impurity 45
- Chemical Name:
- Dapoxetine impurity 18
- Chemical Name:
- Febuxostat Impurity 76
- Chemical Name:
- Febuxostat Impurity 91
- Structure:
- Chemical Name:
- Ipratropium Bromide Impurity 1
- MF:
- C20H29Br2NO3