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.
- Structure:

- Chemical Name:Ixazomib Impurity 1
- CAS:1201903-02-7
- MF:C24H33BCl2N2O4
- Chemical Name:Ofloxacin/Levofloxacin Impurity E
- CAS:
- MF:
- Structure:

- Chemical Name:(3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
- CAS:1026952-91-9
- MF:C13H11F2NO4
- Structure:

- Chemical Name:((4-Methoxyphenoxy)methylene)dibenzene
- CAS:85686-16-4
- MF:C20H18O2
- Chemical Name:Tofacitinib Impurity L
- CAS:
- MF:
- Structure:

- Chemical Name:1-chloro-3-(dimethoxymethyl)benzene
- CAS:3395-80-0
- MF:C9H11ClO2
- Structure:

- Chemical Name:N-(3-bromo-4-oxocyclohexyl)acetamide
- CAS:687639-03-8
- MF:C8H12BrNO2
- Structure:

- Chemical Name:methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate
- CAS:
- MF:C44H51N9O4
- Chemical Name:Alvimopan Impurity 5
- CAS:
- MF:
- Structure:

- Chemical Name:Palbociclib-d8
- CAS:1628752-83-9
- MF:C24H21D8N7O2
- Structure:

- Chemical Name:Ivabradine Impurity 15
- CAS:1132667-04-9
- MF:C12H17NO2
- Chemical Name:Sofosbuvir Impurity27
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 12
- CAS:
- MF:
- Structure:

- Chemical Name:Tacrolimus Impurity 3
- CAS:161861-10-5
- MF:C45H71NO13
- Structure:

- Chemical Name:Aprepitant EP Impurity C
- CAS:2208275-99-2
- MF:C29H25F7N4O3
- Structure:

- Chemical Name:Bisoprolol EP Impurity J
- CAS:1797024-50-0
- MF:C15H24O5
- Structure:

- Chemical Name:Ceftriaxone Impurity
- CAS:79221-95-7
- MF:C18H18N8O8S3
- Structure:

- Chemical Name:Betaxolol EP Impurity E
- CAS:1329613-85-5
- MF:C18H31NO3
- Structure:

- Chemical Name:Tulobuterol Impurity
- CAS:34356-83-7
- MF:C8H5Br2ClO
- Chemical Name:Olaparib Impurity A
- CAS:
- MF:
- Chemical Name:Dapoxetine Impurity 2
- CAS:
- MF:
- Chemical Name:Voriconazole Impurity 5
- CAS:
- MF:
- Structure:

- Chemical Name:tetrahydrofuran-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate
- CAS:1404453-75-3
- MF:C17H22O4
- Chemical Name:Lamivudine impurity 5
- CAS:
- MF:
- Structure:

- Chemical Name:Clopidogrel Impurity 2
- CAS:
- MF:C15H14ClNO2S
- Structure:

- Chemical Name:Mirabegron Impurity 6
- CAS:2762802-64-0
- MF:C10H11ClN4O3S2
- Chemical Name:Pitavastatin Impurity 3
- CAS:
- MF:
- Chemical Name:Solifenacin EP Impurity D
- CAS:
- MF:
- Structure:

- Chemical Name:Cephalexin Impurity 2
- CAS:
- MF:C16H17N3O4S
- Structure:

- Chemical Name:Cefuroxime Impurity 3
- CAS:
- MF:C16H16N4O8S
- Chemical Name:Vonoprazan Impurity 11
- CAS:
- MF:
- Structure:

- Chemical Name:Atracurium Impurity A
- CAS:2724465-40-9
- MF:C28H39NO7
- Chemical Name:Erlotinib Imp.14
- CAS:
- MF:
- Structure:

- Chemical Name:Sorafenib related compound 12
- CAS:284461-74-1
- MF:C20H14ClF3N4O3
- Structure:

- Chemical Name:Apremilast Impurity 10
- CAS:1809170-71-5
- MF:C22H26N2O8S
- Structure:

- Chemical Name:(1R,3S)-Solifenacin Succinate
- CAS:774517-20-3
- MF:C23H26N2O2
- Chemical Name:Dacpomycin Impurity 2
- CAS:
- MF:
- Chemical Name:Nicorandil Impurity 3
- CAS:
- MF:
- Chemical Name:Tacrolimus Impurity A
- CAS:
- MF:
- Structure:

- Chemical Name:1H-Benz[de]isoquinolin-1-one,2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-,(3aR)-
- CAS:135729-73-6
- MF:C19H24N2O
- Chemical Name:Afatinib Impurity 16
- CAS:
- MF:
- Chemical Name:Mirabegron Impurity 19
- CAS:
- MF:
- Structure:

- Chemical Name:(Z)-Mutagenic Impurity of Tenofovir Disoproxil
- CAS:1464851-21-5
- MF:C8H9N5
- Chemical Name:Moxifloxacin impurity (20)
- CAS:
- MF:
- Structure:

- Chemical Name:(R)-2-(2-(tert-butoxy)-2-oxoethyl)pentanoic acid
- CAS:112106-16-8
- MF:C11H20O4
- Chemical Name:Bazedoxifene impurity
- CAS:
- MF:
- Structure:

- Chemical Name:Tamsulosin impurity
- CAS:1429436-97-4
- MF:C20H28N2O5S
- Structure:

- Chemical Name:Clarithromycin (9Z)-Oxime
- CAS:127253-05-8
- MF:C38H70N2O13
- Structure:

- Chemical Name:N-Desmethyl Clarithromycin (9E)-Oxime
- CAS:127182-43-8
- MF:C37H68N2O13
- Structure:

- Chemical Name:Ticagrelor Impurity 24
- CAS:1482484-92-3
- MF:C7H11N3O2S
- Structure:

- Chemical Name:Moxifloxacin Impurity
- CAS:1797982-51-4
- MF:C16H16FNO5
- Chemical Name:sofosBuvir impurity 1
- CAS:
- MF:
- Structure:

- Chemical Name:2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid
- CAS:144060-52-6
- MF:C15H14N2O3S
- Structure:

- Chemical Name:Cyclosporin Impurity 19
- CAS:107335-26-2
- MF:C62H111N11O13
- Chemical Name:Methylprednisolone EP Impurity D1
- CAS:
- MF:
- Chemical Name:Nirmatrelvir Impurity 13
- CAS:
- MF:
- Structure:

- Chemical Name:γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G-heptabromo-6A,6B,6C,6D,6E,6F,6G-heptadeoxy-
- CAS:2458187-21-6
- MF:C48H73Br7O33
- Structure:

- Chemical Name:2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI)
- CAS:611226-36-9
- MF:C7H8N2O2
- Structure:

- Chemical Name:2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI)
- CAS:727375-13-5
- MF:C8H11NO2
- Chemical Name:Bumetanide Impurity 22
- CAS:
- MF:
- Chemical Name:Rocuronium Bromide Impurity 32 、33
- CAS:
- MF:
- Chemical Name:Flucloxacillin Sodium Impurity X
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity J&K
- CAS:
- MF:
- Chemical Name:Olodaterol Impurity 24
- CAS:
- MF:
- Chemical Name:Miglitol Isomer ImpurityB
- CAS:
- MF:
- Chemical Name:43,50-Dicarboxy-cyanoco balamin
- CAS:
- MF:
- Structure:

- Chemical Name:(1R,4S) Sertraline Hydrochloride
- CAS:79896-32-5
- MF:C17H18Cl3N
- Structure:

- Chemical Name:4-Desmethoxy-4-chloro Omeprazole Sulfide
- CAS:220757-74-4
- MF:C16H16ClN3OS
- Structure:

- Chemical Name:2(1H)-Pyrazinone, 3-phenyl-
- CAS:2882-18-0
- MF:C10H8N2O
- Chemical Name:Oseltamivir Impurity 123
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 113
- CAS:
- MF:
- Chemical Name:Avatrombopag Impurity 65
- CAS:
- MF:
- Chemical Name:Apremilast Impurity 46
- CAS:
- MF:
- Structure:

- Chemical Name:Alogliptin Related Compound 26
- CAS:865759-10-0
- MF:C25H24N6O2
- Structure:

- Chemical Name:R-Tirofiban
- CAS:158808-86-7
- MF:C22H36N2O5S
- Chemical Name:Canagliflozin Impurity 20
- CAS:
- MF:
- Chemical Name:Canagliflozin Impurity 6
- CAS:
- MF:
- Chemical Name:Carfilzomib Impurity 6
- CAS:
- MF:
- Structure:

- Chemical Name:Daclatasvir Impurity 5 (SRSS-Isomer)
- CAS:1009117-28-5
- MF:C40H50N8O6
- Structure:

- Chemical Name:Dolutegravir Impurity 7
- CAS:2244161-71-3
- MF:C20H21N3O5
- Chemical Name:Istradefylline Impurity F
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity 22
- CAS:
- MF:
- Structure:

- Chemical Name:Nintedanib impurity G
- CAS:894783-61-0
- MF:C30H31N5O4
- Structure:

- Chemical Name:3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine)
- CAS:1010818-93-5
- MF:C27H34N2O2
- Structure:

- Chemical Name:Febuxostat impurity 36
- CAS:1805770-40-4
- MF:C12H12N2O
- Structure:

- Chemical Name:N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide
- CAS:2031255-27-1
- MF:C28H26N6O3
- Structure:

- Chemical Name:4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
- CAS:
- MF:C8H11FN3O4S-
- Chemical Name:Anastrozole Impurity 3
- CAS:
- MF:
- Structure:

- Chemical Name:Cephalexin Impurity 4
- CAS:
- MF:C16H17N3O4S
- Chemical Name:Rivaroxaban Impurity 42
- CAS:
- MF:
- Structure:

- Chemical Name:(R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid
- CAS:1422514-05-3
- MF:C22H26FN3O6S
- Structure:

- Chemical Name:Atorvastatin 2-Fluoro t-Butyl Ester
- CAS:1099474-28-8
- MF:C40H47FN2O5
- Chemical Name:Cabozantinib Impurity C
- CAS:
- MF:
- Structure:

- Chemical Name:(3R,4R)-N,4-dimethyl-piperidin-3-amine
- CAS:1354469-76-3
- MF:C7H16N2
- Structure:

- Chemical Name:4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine
- CAS:952518-97-7
- MF:C9H7N5
- Structure:

- Chemical Name:5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde
- CAS:881676-90-0
- MF:C16H12N2O3S
- Structure:

- Chemical Name:3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-
- CAS:100332-12-5
- MF:C13H18FNO
- Structure:

- Chemical Name:r-Cytidine
- CAS:13913-16-1
- MF:C9H13N3O5
- Structure:

- Chemical Name:Pyridine, 4-chloro-2-(chloromethyl)-3-methyl-
- CAS:168167-48-4
- MF:C7H7Cl2N