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:
- Celecoxib Impurity 17
- CAS:
- 2247197-65-3
- MF:
- C17H14F3N3O4S
- Chemical Name:
- Dapoxetine impurity 21
- Chemical Name:
- Febuxostat Impurity 74
- Chemical Name:
- Febuxostat Impurity 79
- Chemical Name:
- Febuxostat Impurity 94
- Chemical Name:
- Fosaprepitant Impurity ELS
- Structure:
- Chemical Name:
- Lenvatinib Impurity 14
- CAS:
- 417719-45-0
- MF:
- C19H17ClN4O4
- Chemical Name:
- Lenvatinib Impurity 23
- Chemical Name:
- Olsalazine Impurity F
- Chemical Name:
- Regorafenib Impurity 19
- Chemical Name:
- Regorafenib Impurity 26
- Chemical Name:
- Sitafloxacin Impurity ZZ-B-01
- Structure:
- Chemical Name:
- Tofacitinib Impurity 3
- CAS:
- 1206825-36-6
- MF:
- C13H19N5
- Chemical Name:
- Tofacitinib Impurity 89
- Structure:
- Chemical Name:
- Nintedanib Impurity L
- CAS:
- 2095596-44-2
- MF:
- C31H33N5O4
- Structure:
- Chemical Name:
- (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,11,13- pentahydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6- azacyclopentadecan-15-one
- CAS:
- 117693-42-2
- MF:
- C22H43NO7
- Structure:
- Chemical Name:
- Rizatriptan EP Impurity A
- CAS:
- 887001-08-3
- MF:
- C28H35N7
- Structure:
- Chemical Name:
- Dapoxetine iMpurity
- CAS:
- 38262-42-9
- MF:
- C11H10O3S
- Chemical Name:
- Eltrombopag Impurity 7
- Chemical Name:
- Saxagliptin Impurity 9
- Structure:
- Chemical Name:
- (1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol
- CAS:
- 15992-77-5
- MF:
- C15H22N2O5
- Chemical Name:
- Moxifloxacin degrade Impurity
- Chemical Name:
- Edaravone Impurity 17
- Chemical Name:
- Capecitabine impurity 7
- Chemical Name:
- Linagliptin Impurity 46
- Structure:
- Chemical Name:
- ((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II)
- MF:
- C44H56CaN6O12S2
- Structure:
- Chemical Name:
- Levofloxacin Impurity 24
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- (trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide
- CAS:
- 1932275-13-2
- MF:
- C10H9F2NO
- Structure:
- Chemical Name:
- (3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II)
- CAS:
- 1445208-17-2
- MF:
- C22H28FN3O6S
- Structure:
- Chemical Name:
- Tafluprost Impurity 7
- CAS:
- 733036-94-7
- MF:
- C25H35FO5
- Chemical Name:
- Tropisetron Impurity 1
- Chemical Name:
- Fosaprepitant Impurity DBJ
- Chemical Name:
- Cabozantinib impurity 29
- Chemical Name:
- Cabozantinib impurity 34
- Chemical Name:
- Carfilzomib Impurity YGH
- Chemical Name:
- Ondansetron Impurity 3
- Chemical Name:
- Irsogladine Impurity GDT
- Chemical Name:
- Carvedilol Impurity NH
- Structure:
- Chemical Name:
- Pregabalin Impurity 8
- CAS:
- 44996-52-3
- MF:
- C7H11NO3
- Structure:
- Chemical Name:
- Pregabalin Impurity 14
- CAS:
- 1610546-44-5
- MF:
- C7H11NO3
- Chemical Name:
- Cefditoren Impurity 1
- Structure:
- Chemical Name:
- Cefadroxil Impurity C
- CAS:
- 79962-91-7
- MF:
- C16H17N3O5S
- Structure:
- Chemical Name:
- Pralatrexate Impurity 8
- CAS:
- 112408-16-9
- MF:
- C8H15NO4
- Chemical Name:
- Pitavastatin Impurity 46
- Chemical Name:
- Canagliflozin Impurity 46
- Chemical Name:
- Lenvatinib Impurity 37
- Chemical Name:
- Sitafloxacin Impurity 20
- Chemical Name:
- posaconazole impurity 66
- Chemical Name:
- Dapoxetine impurity 33
- Chemical Name:
- Budesonide Impurity 4
- Chemical Name:
- Atracurium Impurity 31
- Structure:
- Chemical Name:
- Canagliflozin Impurity 49
- CAS:
- 2243132-56-9
- MF:
- C34H35FO11S
- Chemical Name:
- Canagliflozin Impurity 55
- Chemical Name:
- Rosuvastatin Impurity 74
- Structure:
- Chemical Name:
- (S)-IsotiMolol (TiMolol IMpurity B)
- CAS:
- 158636-96-5
- MF:
- C13H24N4O3S
- Chemical Name:
- Afatinib IMpurity A
- Chemical Name:
- Afatinib IMpurity G
- Chemical Name:
- Articaine IMpurity F (Articaine Acid PropionaMide HCl)
- Structure:
- Chemical Name:
- Avanafil iMpurity 4
- CAS:
- 874482-97-0
- MF:
- C8H11Cl2NO
- Structure:
- Chemical Name:
- Clopidogrel IMpurity 4
- CAS:
- 801319-16-4
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- Dehydro Azelnidipine
- CAS:
- 918659-10-6
- MF:
- C33H32N4O6
- Structure:
- Chemical Name:
- DiazepaM IMpurity F
- CAS:
- 31269-33-7
- MF:
- C16H13ClN2O
- Chemical Name:
- LaMotrigine IMpurity
- Structure:
- Chemical Name:
- Posaconazole DiastereoisoMer interMediate 5
- CAS:
- 149809-42-7
- MF:
- C21H21F2N3O4S
- Structure:
- Chemical Name:
- Prasugrel alpha-Hydroxy IMpurity
- CAS:
- 1100905-45-0
- MF:
- C11H11FO2
- Structure:
- Chemical Name:
- Solifenacin Related CoMpound 2 Succinate
- CAS:
- 1262506-09-1
- MF:
- C27H32N2O6
- Structure:
- Chemical Name:
- Tetrahydro FuroseMide
- CAS:
- 4793-38-8
- MF:
- C12H15ClN2O5S
- Structure:
- Chemical Name:
- 6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride
- CAS:
- 183320-04-9
- MF:
- C21H21Cl2N3O3
- Structure:
- Chemical Name:
- LincoMycin 2-Phosphate
- CAS:
- 27480-30-4
- MF:
- C18H35N2O9PS
- Structure:
- Chemical Name:
- Macitentan IMpurity
- CAS:
- 556796-88-4
- MF:
- C17H15Br2N5O4S
- Structure:
- Chemical Name:
- 4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile
- CAS:
- 143030-54-0
- MF:
- C16H11BrN4
- Structure:
- Chemical Name:
- Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]-
- CAS:
- 83881-53-2
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- AlMotriptan Related CoMpound B
- CAS:
- 1246860-65-0
- MF:
- C19H25N3O6S
- Chemical Name:
- Benazepril Related CoMpound B
- Structure:
- Chemical Name:
- IMatinib iMpurity
- CAS:
- 152459-96-6
- MF:
- C24H21N5O
- Structure:
- Chemical Name:
- (2R,3R,4R,5S,6R)-2-(acetoxyMethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate
- CAS:
- 2803372-74-7
- MF:
- C32H33FO9S
- Structure:
- Chemical Name:
- 1,2-BenzenedicarboxaMide, N1,N2-bis[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]-
- CAS:
- 1365267-36-2
- MF:
- C36H36N6O10
- Structure:
- Chemical Name:
- 2-QuinazolineMethanol, 4-Methyl-
- CAS:
- 13535-91-6
- MF:
- C10H10N2O
- Structure:
- Chemical Name:
- 5-(2,2-diMethyl-4H-benzo[d][1,3]dioxin-6-yl)oxazolidin-2-one
- CAS:
- 452340-96-4
- MF:
- C13H15NO4
- Structure:
- Chemical Name:
- N-[6,9-Dihydro-6-oxo-9-[[2-(1-oxopropoxy)-1-[(1-oxopropoxy)methyl]ethoxy]methyl]-1H-purin-2-yl]propanamide
- CAS:
- 177216-32-9
- MF:
- C18H25N5O7
- Structure:
- Chemical Name:
- 5-Bromo-1-(4-fluorophenyl)-1,3-dihydro-N,N-dimethyl-1-isobenzofuranpropanamine ethanedioate (1:1)
- CAS:
- 64372-43-6
- MF:
- C21H23BrFNO5
- Structure:
- Chemical Name:
- (E)-2-Methyl-4-(4-(2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)-10H-benzo[b]thieno[2,3-e][1,4]diazepine
- CAS:
- 1070876-09-3
- MF:
- C28H26N6S2
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-PinanediolN-BOC-L-phenylalanine-L-leucine boronate
- CAS:
- 1187479-72-6
- MF:
- C29H45BN2O5
- Structure:
- Chemical Name:
- Donepezil Impurity 3
- CAS:
- 1023500-88-0
- MF:
- C24H27NO4
- Structure:
- Chemical Name:
- Fesoterodine Related Impurity 4
- CAS:
- 214601-12-4
- MF:
- C22H29NO2
- Structure:
- Chemical Name:
- Prasugrel Impurity 14 Maleate
- CAS:
- 1373350-60-7
- MF:
- C24H25BrFNO7S
- Structure:
- Chemical Name:
- Sofosbuvir Impurity 32
- CAS:
- 1157884-58-6
- MF:
- C20H17FO6
- Structure:
- Chemical Name:
- Torsemide Related Compound 1
- CAS:
- 947327-54-0
- MF:
- C13H13N3O2S
- Structure:
- Chemical Name:
- Vortioxetine Impurity 3
- CAS:
- 508233-82-7
- MF:
- C17H20N2S
- Chemical Name:
- Tofacitinib Impurity 106
- Chemical Name:
- Hydroxychloroquine Impurity J
- Chemical Name:
- Levetiracetam Impurity 25
- Chemical Name:
- Levosimendan Impurity 7
- Chemical Name:
- Cabozantinib impurity K
- Chemical Name:
- Crisaborole Impurity 8
- Chemical Name:
- Trifluridine Impurity B
- Chemical Name:
- Rotigotine Impurity
- Structure:
- Chemical Name:
- Olprinone Impurity 2
- CAS:
- 106730-62-5
- MF:
- C14H12N4O2
- Chemical Name:
- Nicorandil Impurity F
- Chemical Name:
- Nicorandil Impurity A