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.
- Chemical Name:Piperacillin Impurity X
- CAS:
- MF:
- Structure:

- Chemical Name:ETHYLTRITYLETHER
- CAS:968-39-8
- MF:C21H20O
- Chemical Name:Bosutinib Impurity 41
- CAS:
- MF:
- Structure:

- Chemical Name:(S)-3-Dimethylamino-3-phenylpropanol
- CAS:82769-75-3
- MF:C11H17NO
- Structure:

- Chemical Name:2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI)
- CAS:65941-19-7
- MF:C31H40O2
- Structure:

- Chemical Name:Amifostine Impurity 15
- CAS:10297-31-1
- MF:C7H17Br3N2
- Chemical Name:Doxylamine Impurity G
- CAS:
- MF:
- Structure:

- Chemical Name:2,4-Pyrimidinediol, 6-chloro- (9CI)
- CAS:107577-09-3
- MF:C4H3ClN2O2
- Structure:

- Chemical Name:2,4-Pyrimidinediol, 6-chloro- (9CI)
- CAS:107577-09-3
- MF:C4H3ClN2O2
- Chemical Name:Phenoxymethylpenicillin Potassium Impurity 8
- CAS:
- MF:
- Chemical Name:Valdecoxib N-Oxide
- CAS:
- MF:
- Chemical Name:Olodaterol Impurity 23
- CAS:
- MF:
- Chemical Name: Miglitol Isomer impurities C
- CAS:
- MF:
- Structure:

- Chemical Name:8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide
- CAS:2043655-58-7
- MF:C14H19Cl3N2
- Chemical Name:Alpha-D-Methylglucoside
- CAS:
- MF:
- Structure:

- Chemical Name:4-Desacetyl Vincristine
- CAS:3704-01-6
- MF:C44H54N4O9
- Chemical Name: Relugolix Impurity 91
- CAS:
- MF:
- Structure:

- Chemical Name:D,L N-Desmethylvenlafaxine
- CAS:149289-30-5
- MF:C16H25NO2
- Structure:

- Chemical Name:L-GLUCONO-1,5-LACTONE
- CAS:52153-09-0
- MF:C6H10O6
- Structure:

- Chemical Name:C-Desmethyl Atenolol
- CAS:1797116-92-7
- MF:C13H20N2O3
- Structure:

- Chemical Name:Arthromerin B
- CAS:31049-08-8
- MF:C21H22O11
- Structure:

- Chemical Name:Losartan Impurity 7
- CAS:358685-13-9
- MF:C33H24Br2N4
- Structure:

- Chemical Name:Fenofibric Acid 1-Carboxyl-1-methylethyl Ester
- CAS:1797121-54-0
- MF:C21H21ClO6
- Structure:

- Chemical Name:2-Chloro-4'-fluorobenzophenone
- CAS:1806-23-1
- MF:C13H8ClFO
- Structure:

- Chemical Name:Ambrisentan Impurity E
- CAS:1312092-82-2
- MF:C21H18N2O3
- Structure:

- Chemical Name:1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole
- CAS:165115-83-3
- MF:C21H21F2N3O2
- Structure:

- Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid
- CAS:855661-71-1
- MF:C21H24FN3O4
- Chemical Name:4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers)
- CAS:748817-01-8
- MF:
- Structure:

- Chemical Name:Iopamidol Impurity K
- CAS:1788899-70-6
- MF:C17H23I2N3O8
- Structure:

- Chemical Name:N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide
- CAS:87864-08-2
- MF:C16H21N3O2
- Structure:

- Chemical Name:5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid
- CAS:1883595-37-6
- MF:C16H11FN2O4S
- Structure:

- Chemical Name:Ritonavir EP Impurity B
- CAS:765875-58-9
- MF:C28H36N4O4S
- Structure:

- Chemical Name:2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE
- CAS:61698-76-8
- MF:C11H15NO4
- Structure:

- Chemical Name:3-OXO-3-(2,4,5-TRIFLUORO-3-METHOXY-PHENYL)-PROPIONIC ACID ETHYL ESTER
- CAS:112811-68-4
- MF:C12H11F3O4
- Structure:

- Chemical Name:2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-N5,N5- dimethylpyrimidine-4,5,6-triamine
- CAS:1169770-52-8
- MF:C19H19FN8
- Structure:

- Chemical Name:3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
- CAS:153139-56-1
- MF:C16H20N2O
- Structure:

- Chemical Name:6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dihydro-8H-purin-8-one
- CAS:1361569-10-9
- MF:C18H13FN8O
- Chemical Name:Apremilast impurity 32
- CAS:
- MF:
- Chemical Name:Baricitinib Impurity 5
- CAS:
- MF:
- Chemical Name:Bendamustine Impurity 28
- CAS:
- MF:
- Chemical Name:Bortezomib Impurity 20
- CAS:
- MF:
- Structure:

- Chemical Name:Canagliflozin Impurity 27
- CAS:2265214-89-7
- MF:C18H14BrFS
- Structure:

- Chemical Name:ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5- carboxylate
- CAS:2230270-05-8
- MF:C18H20N2O3S
- Chemical Name:Cefminox Sodium Impurity 6
- CAS:
- MF:
- Chemical Name:Flurbiprofen Impurity 7
- CAS:
- MF:
- Structure:

- Chemical Name:Imidafenacin Impurity 8
- CAS:503598-05-8
- MF:C20H21N3O3
- Structure:

- Chemical Name:Pregabalin Impurity E
- CAS:1239692-16-0
- MF:C11H24ClNO2
- Chemical Name:Rosuvastatin Impurity 86
- CAS:
- MF:
- Chemical Name:Cefathiamidine Impurity 8
- CAS:
- MF:
- Structure:

- Chemical Name:Urapidil impurity 7
- CAS:108997-11-1
- MF:C24H34N4O2
- Structure:

- Chemical Name:methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate.
- CAS:2089061-92-5
- MF:C17H17ClN2O3
- Chemical Name:Pregabalin Impurity 15
- CAS:
- MF:
- Chemical Name:Pregabalin Impurity 32
- CAS:
- MF:
- Structure:

- Chemical Name:4-Hydroxyphthalic Acid
- CAS:501666-22-4
- MF:C14H25NO6
- Chemical Name:Edoxaban Impurity 23 (1S,2S,4R)
- CAS:
- MF:
- Structure:

- Chemical Name:Edoxaban Impurity 38
- CAS:2081883-53-4
- MF:C14H27N3O3
- Structure:

- Chemical Name:Ezetimibe Impurity 33
- CAS:1829558-53-3
- MF:C13H10FNO
- Chemical Name:Imatinib Impurity 14
- CAS:
- MF:
- Structure:

- Chemical Name:Levofloxacin Impurity 20
- CAS:2489671-29-4
- MF:C18H20FN3O4
- Chemical Name:Pantoprazole Impurity 12
- CAS:
- MF:
- Chemical Name:Solifenacin Related Compound 7
- CAS:
- MF:
- Structure:

- Chemical Name:Vonoprazan Impurity 12
- CAS:3058423-29-0
- MF:C23H21F2N3
- Chemical Name:Apixaban Impurity 22
- CAS:2847836-17-1
- MF:
- Chemical Name:Avibactam Impurity A
- CAS:
- MF:
- Chemical Name:Avibactam Impurity F
- CAS:
- MF:
- Chemical Name:Brexpiprazole Impurity K
- CAS:
- MF:
- Chemical Name:Cefaclor Impurity 3
- CAS:
- MF:
- Structure:

- Chemical Name:Milrinone Impurity 7
- CAS:2250242-59-0
- MF:C14H13N3O
- Chemical Name:Silodosin Impurity 1
- CAS:
- MF:
- Chemical Name:Sulpiride Impurity 1
- CAS:
- MF:
- Chemical Name:Tenofovir Impurity 54
- CAS:
- MF:
- Structure:

- Chemical Name:Trelagliptin Impurity Y
- CAS:1938080-42-2
- MF:C13H10FN3O3
- Structure:

- Chemical Name:Trelagliptin Impurity Y
- CAS:1938080-42-2
- MF:C13H10FN3O3
- Chemical Name:Cefathiamidine Impurity 10
- CAS:
- MF:
- Structure:

- Chemical Name:Nebivolol Impurity 3
- CAS:1029684-20-5
- MF:C18H20FNO2
- Structure:

- Chemical Name:Pemetrexed
- CAS:155405-79-1
- MF:C12H13BrO3
- Chemical Name:Axitinib Impurity 14
- CAS:
- MF:
- Chemical Name:Nicorandil Impurity 7
- CAS:
- MF:
- Structure:

- Chemical Name:Ritonavir EP Impurity T
- CAS:869368-48-9
- MF:C46H66N8O5S2
- Structure:

- Chemical Name:4-Methoxy-a-methyl-L-phenylalanine
- CAS:65555-88-6
- MF:C11H15NO3
- Structure:

- Chemical Name:Cyanocobalamin
- CAS:38218-55-2
- MF:C63H87CoN13O15P
- Chemical Name:Empagliflozin Impurity 44
- CAS:
- MF:
- Structure:

- Chemical Name:1,4,8,11- tetra(trifluoroacetyl)-1,4,8,11-tetraazacyclotetradecane
- CAS:201610-16-4
- MF:C18H20F12N4O4
- Structure:

- Chemical Name:5-bromo-4-(4-chlorothiophen-2-yl)thiazol-2-amine
- CAS:2161380-87-4
- MF:C7H4BrClN2S2
- Chemical Name:Zopiclone Impurity 11
- CAS:
- MF:
- Structure:

- Chemical Name:(3R,5S)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonam ido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate calcium(II)
- CAS:854898-49-0
- MF:C44H54CaF2N6O12S2
- Structure:

- Chemical Name:Doxorubicin EP Impurity C HBr
- CAS:60873-68-9
- MF:C27H29Br2NO10
- Chemical Name:Ceftazidime Impurity K
- CAS:
- MF:
- Structure:

- Chemical Name:Furosemide Impurity 3
- CAS:
- MF:C12H11ClN2O5S
- Structure:

- Chemical Name:Nicorandil Impurity 13
- CAS:19416-51-4
- MF:C9H11NO3
- Chemical Name:Rosuvastatin Impurity 51
- CAS:
- MF:
- Structure:

- Chemical Name:Silodosin Impurity 3
- CAS:1402161-34-5
- MF:C29H31N3O2
- Chemical Name:Tenofovir Impurity 61
- CAS:
- MF:
- Structure:

- Chemical Name:Ticagrelor Impurity 70
- CAS:1824025-11-7
- MF:C10H9F2NO
- Structure:

- Chemical Name:Topiroxostat Impurity 21
- CAS:2044704-74-5
- MF:C13H7N5O
- Structure:

- Chemical Name:Mirabegron Impurity 17
- CAS:1684452-84-3
- MF:C31H32N8O4S3
- Chemical Name:Afatinib Impurity 24
- CAS:
- MF:
- Structure:

- Chemical Name:Amifostine Impurity 8
- CAS:66487-25-0
- MF:C5H10N2O
- Chemical Name:Bendamustine Impurity 33
- CAS:
- MF:
- Chemical Name:Bendamustine Impurity 38
- CAS:
- MF: