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:
- Empagliflozin Impurity 34
- Structure:
- Chemical Name:
- Sugammadex Impurity 22
- CAS:
- 2412952-94-2
- MF:
- C72H113NaO48S8
- Structure:
- Chemical Name:
- Febuxostat
- CAS:
- 1312815-36-3
- MF:
- C20H25NO4S
- Structure:
- Chemical Name:
- Itraconazole Impurity 34
- CAS:
- 103661-14-9
- MF:
- C14H15Cl2N3O5S
- Structure:
- Chemical Name:
- Lansoprazole Impurity 34
- CAS:
- 1357726-93-2
- MF:
- C7H8N2O3
- Structure:
- Chemical Name:
- Meloxicam Impurity 1 HCl
- CAS:
- 929568-25-2
- MF:
- C4H7ClN2O
- Structure:
- Chemical Name:
- Palonosetron Impurity 11
- CAS:
- 2216753-67-0
- MF:
- C18H24N2O
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 10
- CAS:
- 461432-27-9
- MF:
- C21H25ClO7
- Structure:
- Chemical Name:
- Levetiracetam impurity 2
- CAS:
- 1341459-52-6
- MF:
- C8H17N3O2
- Structure:
- Chemical Name:
- (S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide
- CAS:
- 2204368-63-6
- MF:
- C23H21Cl2N3O5S2
- Structure:
- Chemical Name:
- Ezetimibe Impurity 38
- CAS:
- 1701462-59-0
- MF:
- C45H58F2N2O5Si2
- Structure:
- Chemical Name:
- Indapamide Impurity F
- CAS:
- 62574-66-7
- MF:
- C7H3Cl3O3S
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 38
- CAS:
- 1262758-66-6
- MF:
- C21H24FN3O5
- Structure:
- Chemical Name:
- Nimodipine Impurity 3
- CAS:
- 101072-61-1
- MF:
- C11H9NO5
- Chemical Name:
- Pitavastatin Impurity 40
- Chemical Name:
- Ritonavir EP Impurity R
- Structure:
- Chemical Name:
- Ticagrelor Impurity 68
- CAS:
- 1643378-46-4
- MF:
- C23H29FN6O4S
- Chemical Name:
- Tofacitinib Impurity 70
- Chemical Name:
- Afatinib Impurity 22
- Chemical Name:
- Amifostine Impurity 6
- Chemical Name:
- Apixaban Impurity 33
- Chemical Name:
- Aztreonam Impurity 6
- Structure:
- Chemical Name:
- Clarithromycin Impurity EP G
- CAS:
- 107216-09-1
- MF:
- C39H72N2O13
- Chemical Name:
- Dapagliflozin Impurity 32
- Structure:
- Chemical Name:
- Doxofylline Impurity 7
- CAS:
- 43135-57-5
- MF:
- C13H20N4O4
- Chemical Name:
- Erlotinib Impurity 55
- Chemical Name:
- Etoposide Impurity 1
- Chemical Name:
- Etoposide Impurity 6
- Chemical Name:
- Olaparib Impurity 34
- Structure:
- Chemical Name:
- Oseltamivir Impurity 15
- CAS:
- 2254819-34-4
- MF:
- C22H36N2O4
- Chemical Name:
- Oseltamivir Impurity 27
- Chemical Name:
- Pitavastatin Impurity 20
- Chemical Name:
- Rocuronium Bromide Impurity 20
- Chemical Name:
- Rocuronium Bromide Impurity 9
- Structure:
- Chemical Name:
- Palbociclib Impurity 91
- CAS:
- 571191-15-6
- MF:
- C22H27N7O2
- Structure:
- Chemical Name:
- Ibrutinib Impurity 28
- CAS:
- 2213398-75-3
- MF:
- C18H15N5O
- Structure:
- Chemical Name:
- Clopidogrel Impurity 60
- CAS:
- 1430373-12-8
- MF:
- C25H26ClNO6S
- Chemical Name:
- Ozagrel Impurity F
- Structure:
- Chemical Name:
- Ceftriaxone Sodium impurity 1
- CAS:
- 1214622-93-1
- MF:
- C10H12N2O5S
- Chemical Name:
- Lasoprazole impurity
- Structure:
- Chemical Name:
- 677007-73-7
- CAS:
- 677007-73-7
- MF:
- C6H4BrClOS
- Structure:
- Chemical Name:
- Fluticasone Impurity 14
- MF:
- C25H31F3O5S
- Chemical Name:
- Ritonavir EP Impurity U
- Structure:
- Chemical Name:
- ((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II)
- MF:
- C66H68CaF2N4O10
- Chemical Name:
- DexMedetoMidine IMpurity O
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 48
- CAS:
- 1414932-72-1
- MF:
- C21H20ClN3O4
- Chemical Name:
- Imatinib Impurity A
- Chemical Name:
- Vonoprazan Impurity 19
- Structure:
- Chemical Name:
- Pregabalin Diacid
- CAS:
- 1788341-42-3
- MF:
- C16H26N2O
- Chemical Name:
- Dexamethasone Impurity A
- Chemical Name:
- Olaparib Impurity 24
- Chemical Name:
- Topiroxostat Impurity 6
- Chemical Name:
- Irinotecan EP Impurity H
- Chemical Name:
- Teneligliptin Impurity 4
- Structure:
- Chemical Name:
- 1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT
- CAS:
- 51138-06-8
- MF:
- C2H3N4NaS
- Structure:
- Chemical Name:
- 5-HYDROXY LANSOPRAZOLE
- CAS:
- 131926-98-2
- MF:
- C16H14F3N3O3S
- Structure:
- Chemical Name:
- ergosteryl 3-beta-D-glucoside
- CAS:
- 130155-33-8
- MF:
- C34H54O6
- Structure:
- Chemical Name:
- (3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid
- MF:
- C22H23NO4
- Structure:
- Chemical Name:
- Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate
- MF:
- C27H35NO5
- Structure:
- Chemical Name:
- 2-(((3aS,4R,6S,6aR)-6-((5-amino-6-chloro-2-(propylthio)pyrimidin-4-yl)amino)-2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethan-1-ol
- MF:
- C17H27ClN4O4S
- Structure:
- Chemical Name:
- Clindamycin impurity
- CAS:
- 198080-64-7
- MF:
- C18H32N2O5S
- Chemical Name:
- Digoxin impurity
- Chemical Name:
- Lamivudine impurity
- Structure:
- Chemical Name:
- Levothyroxine Sodium impurity
- CAS:
- 27566-09-2
- MF:
- C14H21NO4
- Structure:
- Chemical Name:
- Dexchlorpheniramine impurity
- CAS:
- 73775-50-5
- MF:
- C12H15ClN2
- Structure:
- Chemical Name:
- (S)-N-(2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
- CAS:
- 1384441-38-6
- MF:
- C21H22N2O7S
- Structure:
- Chemical Name:
- (1R,2S,3S)-Aprepitant
- CAS:
- 172822-28-5
- MF:
- C23H21F7N4O3
- Structure:
- Chemical Name:
- 6-benzyloxy-8-((R)-2-chloro-1-hydroxy-ethyl)-4H-benzo[1,4]-oxazin-3-one
- CAS:
- 869478-11-5
- MF:
- C17H16ClNO4
- Structure:
- Chemical Name:
- ethyl (41R,13aS)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:
- 77549-94-1
- MF:
- C22H26N2O2
- Chemical Name:
- Dolutegravir Impurity 2
- Structure:
- Chemical Name:
- Lesinurad Impurity J
- CAS:
- 1210330-64-5
- MF:
- C14H10BrN3O2S
- Structure:
- Chemical Name:
- Neratinib Impurity 4
- CAS:
- 1144516-18-6
- MF:
- C31H32ClN6O3+
- Structure:
- Chemical Name:
- Avibactam Impurity 3(2R,5S)
- CAS:
- 1383814-68-3
- MF:
- C7H12N3NaO6S
- Structure:
- Chemical Name:
- Linagliptin Impurity C
- CAS:
- 1791405-13-4
- MF:
- C15H20N6O2
- Structure:
- Chemical Name:
- 1,1-Cyclopropanedicarboxamide,N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-phenyl-
- CAS:
- 849221-94-9
- MF:
- C28H25N3O5
- Structure:
- Chemical Name:
- methyl (41S,12S,13aS)-13a-ethyl-12-hydroxy-8-methoxy-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:
- 57430-34-9
- MF:
- C22H28N2O4
- Structure:
- Chemical Name:
- (R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]ethanone
- CAS:
- 1288338-95-3
- MF:
- C24H24N6O2
- Structure:
- Chemical Name:
- Amlodipine Impurity 17
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Edoxaban Impurity 12 (1R,2R,4S)
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 26
- CAS:
- 1838133-00-8
- MF:
- C23H21Cl2N3O5S2
- Structure:
- Chemical Name:
- Erlotinib
- CAS:
- 938185-06-9
- MF:
- C16H11N3O2
- Chemical Name:
- Erlotinib Hydrochloride iMpurity 53
- Structure:
- Chemical Name:
- (3R,4S)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate
- CAS:
- 2389152-22-9
- MF:
- C26H24FNO5
- Structure:
- Chemical Name:
- Chemtrue-RL-N5
- CAS:
- 1589503-97-8
- MF:
- C26H27F2N3O6S
- Chemical Name:
- Moxifloxacin EP Impurity K
- Chemical Name:
- Anestagnate
- Chemical Name:
- Trelagliptin IMpurity 33
- Structure:
- Chemical Name:
- Estradiol Impurity 1
- CAS:
- 57780-81-1
- MF:
- C18H24O4
- Structure:
- Chemical Name:
- Metoprolol IMpurity L
- MF:
- C15H25NO3
- Chemical Name:
- Teneligliptin Impurity 14
- Chemical Name:
- Ampicillin EP Impurity P
- Structure:
- Chemical Name:
- 5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5E)-
- CAS:
- 1563176-58-8
- MF:
- C25H34F2O5
- Structure:
- Chemical Name:
- Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester
- CAS:
- 477877-98-8
- MF:
- C26H40O5
- Structure:
- Chemical Name:
- 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide
- CAS:
- 1997296-62-4
- MF:
- C13H12F2N6O2
- Structure:
- Chemical Name:
- para-Hydroxy L-Milnacipran
- CAS:
- 688738-11-6
- MF:
- C15H22N2O2
- Chemical Name:
- Varenicline Impurity 9
- Chemical Name:
- Elagolix Sodium impurity3
- Structure:
- Chemical Name:
- Epinephrine Impurity 4
- CAS:
- 94217-53-5
- MF:
- C9H13NO3
- Structure:
- Chemical Name:
- (trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O