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:
- (2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((R)-tetrahydrofuran- 3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H- pyran-3,4,5-triol
- MF:
- C23H27ClO7
- Structure:
- Chemical Name:
- Afatinib impurity 34
- CAS:
- 2475095-50-0
- MF:
- C14H7ClF2N4O2
- Structure:
- Chemical Name:
- Avibactam Impurity 39
- CAS:
- 2089462-91-7
- MF:
- C15H22N2O3
- Chemical Name:
- Butyphthalide impurity 28
- Structure:
- Chemical Name:
- Butyphthalide impurity 36
- CAS:
- 2245275-82-3
- MF:
- C15H18O5
- Chemical Name:
- Canagliflozin Impurity 32
- Chemical Name:
- Carbocistein Impurity B
- Structure:
- Chemical Name:
- Celecoxib Impurity 22
- CAS:
- 921617-76-7
- MF:
- C17H13F3N2O3S
- Chemical Name:
- Emtricitabine Impurity RRO
- Chemical Name:
- Febuxostat Impurity 84
- Chemical Name:
- Febuxostat Impurity 89
- Chemical Name:
- Gefitinib Impurity T
- Chemical Name:
- Ibrutinib Impurity 16
- Chemical Name:
- LCZ696(valsartan + sacubitril) impurity 35
- Chemical Name:
- Lenvatinib Impurity 15
- Chemical Name:
- Montelukast sodium impurity I
- Chemical Name:
- Moxifloxacin Impurity 48
- Chemical Name:
- Olsalazine Impurity A
- Chemical Name:
- Ozagrel impurity E
- Chemical Name:
- Solifenacin impurity 22
- Chemical Name:
- Sunitinib Impurity YDEJ
- Chemical Name:
- Tofacitinib Impurity 94
- Chemical Name:
- Topiroxostat Impurity 31
- Chemical Name:
- Sitafloxacin Impurity 9 Sodium Salt
- Structure:
- Chemical Name:
- Azilsartan Impurity 11
- CAS:
- 91526-16-8
- MF:
- C12H12O6S
- Structure:
- Chemical Name:
- Pitavastatin Impurity 18 Sodium Salt
- CAS:
- 1611499-16-1
- MF:
- C25H24FNO5
- Structure:
- Chemical Name:
- Apixaban Impurity 25
- CAS:
- 2133292-60-9
- MF:
- C26H27ClN4O5
- Chemical Name:
- Saxagliptin Impurity 10
- Structure:
- Chemical Name:
- (1r,4r)-4-((2-amino-4-bromobenzyl)amino)cyclohexan-1-ol hydrochloride
- MF:
- C13H20BrClN2O
- Chemical Name:
- Aztreonam Impurity 6
- Structure:
- Chemical Name:
- Cetirizine impurity 14
- MF:
- C21H25ClN2O3
- Structure:
- Chemical Name:
- Vitamin B1 Impurity 1
- MF:
- C12H17ClN4OS
- Structure:
- Chemical Name:
- Diquafosol Impurity UP2U
- CAS:
- 221169-12-6
- MF:
- C18H25N4NaO17P2
- Structure:
- Chemical Name:
- Pemetrexed disodium Impurity
- CAS:
- 17405-00-4
- MF:
- C7H5ClN2O2
- Chemical Name:
- Vonoprazan Impurity Z-1
- Chemical Name:
- IPC-Mixed Tenofovir Trimer
- Structure:
- Chemical Name:
- Olanzapine impurity M
- MF:
- C17H20N4S
- Structure:
- Chemical Name:
- Afatinib impurity 41
- CAS:
- 69169-63-7
- MF:
- C5H9NO2
- Structure:
- Chemical Name:
- Vildagliptin Impurity 38
- CAS:
- 956508-24-0
- MF:
- C10H16N2O3
- Chemical Name:
- Tazobactam Impurity C
- Chemical Name:
- Palonosetron Impurity TM1-YA
- Chemical Name:
- Pitavastatin Impurity 33
- Chemical Name:
- Pralatrexate Impurity 14
- Chemical Name:
- Pitavastatin Impurity 51
- Chemical Name:
- Pitavastatin Impurity 59
- Chemical Name:
- Lenvatinib Impurity 42
- Chemical Name:
- Tazobactam Impurity 8
- Chemical Name:
- Prednicarbate Impurity B
- Chemical Name:
- Doxofylline Impurity 13
- Chemical Name:
- Afatinib impurity 46
- Chemical Name:
- Canagliflozin Impurity 60
- Chemical Name:
- Canagliflozin Impurity 65
- Chemical Name:
- Rosuvastatin Impurity 75
- Chemical Name:
- Acyclovir Impurity 11
- Chemical Name:
- Selexipag Impurity 6
- Chemical Name:
- Cabozantinib impurity N
- Structure:
- Chemical Name:
- Barcitinib impurity-09
- CAS:
- 1187594-16-6
- MF:
- C14H13N7
- Chemical Name:
- Rotigotine Impurity 6
- Structure:
- Chemical Name:
- Olprinone Impurity 7
- CAS:
- 2236020-10-1
- MF:
- C9H10N2
- Chemical Name:
- Cilastatin Impurity 2
- Chemical Name:
- Cilastatin Impurity 7
- Structure:
- Chemical Name:
- Dabrafenib Impurity 1
- CAS:
- 1907654-22-1
- MF:
- C24H21F3N4O3S2
- Structure:
- Chemical Name:
- Eliglustat Impurity 2（Eliglustat SR-Isomer）
- CAS:
- 1092472-66-6
- MF:
- C23H36N2O4
- Structure:
- Chemical Name:
- Tamsulosin impurity C
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- Umeclidinium Bromide Impurity 9 DiHCl
- CAS:
- 494778-36-8
- MF:
- C18H32N2O4
- Chemical Name:
- Flucloxacillin Impurity 4
- Structure:
- Chemical Name:
- Ipratropium bromide Impurity 4
- MF:
- C20H29Br2NO3
- Chemical Name:
- Cefminox Impurity 6
- Chemical Name:
- Afatinib Impurity 55
- Chemical Name:
- Apremilast Impurity 30
- Structure:
- Chemical Name:
- Aprepitant Impurity 33
- CAS:
- 502537-39-5
- MF:
- C20H20F7NO3
- Chemical Name:
- Brivaracetam Impurity 9
- Chemical Name:
- Esomeprazole Impurity 43
- Chemical Name:
- Etoricoxib Impurity 40
- Chemical Name:
- Lenvatinib Impurity 31
- Structure:
- Chemical Name:
- Oseltamivir Impurity 35
- CAS:
- 757965-01-8
- MF:
- C14H22O4
- Chemical Name:
- Palbociclib Impurity 39
- Chemical Name:
- Posaconazole Impurity 75
- Chemical Name:
- Rabeprazole Impurity 22
- Chemical Name:
- Sunitinib Impurity 12
- Chemical Name:
- Ticagrelor Impurity 113
- Chemical Name:
- Ticagrelor Impurity 97
- Chemical Name:
- Tofacitinib Impurity 117
- Chemical Name:
- Trelagliptin Impurity 22
- Chemical Name:
- Trelagliptin Impurity 29
- Chemical Name:
- Vildagliptin Impurity 43
- Chemical Name:
- Dexchlorpheniramine impurity F
- Structure:
- Chemical Name:
- Irbesartan IMpurity F
- MF:
- C25H28N6O
- Chemical Name:
- Itraconazole iMpurity 2
- Chemical Name:
- Palbociclib Impurity 6
- Chemical Name:
- Azacitidine Impurity 1
- Chemical Name:
- Saxagliptin Impurity 5
- Chemical Name:
- Cinacalcet Impurity 18
- Structure:
- Chemical Name:
- Erlotinib Impurity 23
- CAS:
- 2021249-11-4
- MF:
- C23H18F6N6O
- Chemical Name:
- Erlotinib Impurity 36
- Chemical Name:
- Fasudil Impurity 17
- Chemical Name:
- Febuxostat Impurity 50
- Chemical Name:
- Varenicline Impurity 8
- Chemical Name:
- Ticagrelor Impurity 53
- CAS:
- 2750247-77-7
- Chemical Name:
- Edoxaban Impurity 5