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:
- 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:
- Lasmiditan Impurity 9
- Chemical Name:
- Letermovir Impurity 2
- Structure:
- Chemical Name:
- 1H-Imidazole-2-carboxylic acid
- CAS:
- 16042-25-4
- MF:
- C4H4N2O2
- 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
- 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
- Chemical Name:
- Flomoxef Impurity IV
- Chemical Name:
- Pitavastatin Impurity 54 Complete Set
- Chemical Name:
- Cetrorelix Impurity 15
- Chemical Name:
- Brivaracetam Impurity 46
- Chemical Name:
- Atracurium Impurity H Complete Set
- Chemical Name:
- Peramivir Intermediate Impurity 38
- Chemical Name:
- Ticagrelor impurity P drops
- Chemical Name:
- Oxacillin sodium EP impurity J
- Chemical Name:
- Piperacillin Sodium EP Impurity P
- Chemical Name:
- (S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity B(USP)
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2458312-06-4
- MF:
- C27H30N2O6
- Structure:
- Chemical Name:
- 15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA
- CAS:
- 41639-71-8
- MF:
- C23H32O5
- Chemical Name:
- (5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
- Structure:
- Chemical Name:
- Acetamide, N-(4-hydroxyphenyl)-N-nitroso-
- CAS:
- 146897-60-1
- MF:
- C8H8N2O3
- Chemical Name:
- RICE BRAN OIL
- CAS:
- 68553-81-1
- Structure:
- Chemical Name:
- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]-
- CAS:
- 2402776-83-2
- MF:
- C16H17N7O2S
- Chemical Name:
- Iohexol ImpuritiesE
- Structure:
- Chemical Name:
- TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE
- CAS:
- 404958-08-3
- MF:
- C10H17ClO4
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
- Chemical Name:
- Bumetanide Photodegradable Impurity 16
- Chemical Name:
- Bisoprolol Impurity 47
- Chemical Name:
- Gadobutrol Impurity 11(Ammonium salt)
- Chemical Name:
- Flomoxef Impurity F
- Chemical Name:
- Tegoprazan Impurity 15
- Chemical Name:
- Nirmatrelvir Impurity 8
- Chemical Name:
- Nirmatrelvir Impurity 2
- Chemical Name:
- (5-(2-fluorophenyl)-1H-pyrrol-3-yl)methanamine hydrochloride
- Chemical Name:
- Rocuronium Bromide Impurity 24 、25
- Chemical Name:
- Roxadustat Impurity 17
- Chemical Name:
- Perospirone Impurity 20
- CAS:
- 1002359-81-0
- Chemical Name:
- Dolutegravir Impurity 19
- Chemical Name:
- Cephalexin Impurity I
- Chemical Name:
- Fondaparinux sodium impurity 6
- Chemical Name:
- Fondaparinux sodium impurity 2
- Chemical Name:
- Oxacillin sodium Impurity I
- Chemical Name:
- Mixture of Cefoxitin Impurity E&F
- Chemical Name:
- Revefenacin Impurity 22
- Chemical Name:
- Lasmiditan Impurity 7
- Chemical Name:
- Febuxostat impurity BAC
- Structure:
- Chemical Name:
- 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL
- CAS:
- 866018-46-4
- MF:
- C16H14Cl2O
- Chemical Name:
- Olodaterol Impurity 19
- Chemical Name:
- Ethacridine Impurity 12