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:Olaparib impurity 1
- CAS:763113-06-0
- MF:C24H24N4O3
- Structure:

- Chemical Name:4-Quinazolinamine,N-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-,hydrochloride(1:1)
- CAS:1624294-38-7
- MF:C22H26ClN3O4
- Structure:

- Chemical Name:4-Oxiranylmethoxy-benzaldehyde
- CAS:14697-49-5
- MF:C10H10O3
- Structure:

- Chemical Name:Alogliptin Related Compound 24
- CAS:1430222-06-2
- MF:C14H12ClN3O2
- Chemical Name:Apremilast Impurity 1
- CAS:
- MF:
- Structure:

- Chemical Name:Etoricoxib Impurity 15
- CAS:73312-69-3
- MF:C5H8ClNO
- Chemical Name:Ibrutinib Impurity 1
- CAS:
- MF:
- Chemical Name:Mirabegron Impurity 13
- CAS:
- MF:
- Chemical Name:Riociguat Impurtiy 4
- CAS:
- MF:
- Structure:

- Chemical Name:2,3-Dehydrosilybin B
- CAS:142796-24-5
- MF:C25H20O10
- Structure:

- Chemical Name:Cabozantinib Impurity
- CAS:1355031-15-0
- MF:C16H14N2O3
- Chemical Name:Canagliflozin open-ring impurity
- CAS:
- MF:
- Chemical Name:Dapoxetine Impurity E
- CAS:
- MF:
- Structure:

- Chemical Name:Ilaprazole Impurity
- CAS:1018229-53-2
- MF:C11H9N3O
- Chemical Name:Linagliptin Impurity X
- CAS:
- MF:
- Structure:

- Chemical Name:Norfloxacin Imp.(EP)
- CAS:1911573-08-4
- MF:C34H52FN3O4
- Structure:

- Chemical Name:Ondansetron EP Impurity H
- CAS:201409-17-8
- MF:C17H18ClN3O
- Structure:

- Chemical Name:Rocuronium Bromide Impurity
- CAS:13492-57-4
- MF:C27H44N2O4
- Chemical Name:Ruxolitinib Impurity
- CAS:
- MF:
- Chemical Name:Roxithromycin h
- CAS:
- MF:
- Chemical Name:Ixazomib Impurity 2
- CAS:
- MF:
- Structure:

- Chemical Name:sildenafil impurity I
- CAS:
- MF:C22H30N6O4S
- Structure:

- Chemical Name:2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni
- CAS:120511-92-4
- MF:C17H19N5
- Structure:

- Chemical Name:2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-4-ylmethyl)phenyl]-2-methyl-propaneni
- CAS:120511-92-4
- MF:C17H19N5
- Structure:

- Chemical Name:Benzoic acid, 4-(3-hydroxy-1-propenyl)-, ethyl ester
- CAS:89113-43-9
- MF:C12H14O3
- Structure:

- Chemical Name:1-((2S,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione
- CAS:2041584-99-8
- MF:C10H13FN2O5
- Structure:

- Chemical Name:2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine
- CAS:1353428-89-3
- MF:C13H17NO
- Structure:

- Chemical Name:2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine
- CAS:1353428-89-3
- MF:C13H17NO
- Structure:

- Chemical Name:Dapoxetine Impurity 13
- CAS:156453-50-8
- MF:C19H18O2
- Structure:

- Chemical Name:Terbutaline Impurity 4
- CAS:52144-92-0
- MF:C33H35NO3
- Structure:

- Chemical Name:5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine
- CAS:1823404-28-9
- MF:C9H11BrClN3
- Structure:

- Chemical Name:(3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid
- CAS:1714147-47-3
- MF:C25H36CaFN3O7S
- Structure:

- Chemical Name:delphinidin 3-O-beta-D-glucoside
- CAS:50986-17-9
- MF:C21H21O12+
- Structure:

- Chemical Name:isorhamnetin 7-O-beta-D-glucopyranoside
- CAS:6743-96-0
- MF:C22H22O12
- Structure:

- Chemical Name:N-(2,6-dimethylphenyl)nicotinamide
- CAS:84951-65-5
- MF:C14H14N2O
- Structure:

- Chemical Name:Difluoro Atorvastatin Acetonide tert-Butyl Ester
- CAS:693793-87-2
- MF:C40H46F2N2O5
- Structure:

- Chemical Name:Tirofiban hydrochloride Impurity 6
- CAS:2250244-31-4
- MF:C17H27NO7S2
- Structure:

- Chemical Name:Demiditraz IMpurity
- CAS:944268-65-9
- MF:C20H20N2
- Chemical Name:Aprepitant Impurity 16
- CAS:850354-60-8
- MF:
- Structure:

- Chemical Name:Aripiprazole impurity 20
- CAS:203395-83-9
- MF:
- Structure:

- Chemical Name:Aripiprazole impurity 20
- CAS:203395-83-9
- MF:
- Chemical Name:Blonanserin impurity H
- CAS:
- MF:
- Chemical Name:Captopril impurity 1
- CAS:
- MF:
- Chemical Name:Cefodizime Impurity 6
- CAS:
- MF:
- Chemical Name:Clindamycin Impurity 5
- CAS:
- MF:
- Chemical Name:Dapoxetine Impurity 16
- CAS:
- MF:
- Chemical Name:Doxofylline Impurity 5
- CAS:
- MF:
- Chemical Name:Everolimus impurity B
- CAS:
- MF:
- Chemical Name:FeBuxostat Impurity 27
- CAS:
- MF:
- Structure:

- Chemical Name:Fosaprepitant Impurity 1
- CAS:172822-01-4
- MF:C23H22F7N4O6P
- Structure:

- Chemical Name:Hydroxychloroquine Impurity 7
- CAS:47493-14-1
- MF:C20H28ClN3O2
- Structure:

- Chemical Name:Indacaterol Impurity 12
- CAS:1026461-20-0
- MF:C22H24N2O3
- Chemical Name:Isavuconazole Impurity 15
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 3
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 8
- CAS:
- MF:
- Chemical Name:Lenvatinib Impurity 3
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity 44
- CAS:
- MF:
- Chemical Name:MiraBegron impurity E
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 16
- CAS:
- MF:
- Structure:

- Chemical Name:Nifedipine Impurity H
- CAS:74936-71-3
- MF:C16H16N2O6
- Chemical Name:Plerixafor Impurity 3
- CAS:
- MF:
- Chemical Name:Posaconazole Impurity 27
- CAS:
- MF:
- Structure:

- Chemical Name:Posaconazole Impurity 44
- CAS:357189-97-0
- MF:C21H20F2N4O3
- Chemical Name:Pramipexole Impurity 10
- CAS:
- MF:
- Chemical Name:rac N-Propyl-2-cyanimidopyrrolidine-5-acetic Acid
- CAS:
- MF:
- Chemical Name:sofosBuvir Impurity 33
- CAS:
- MF:
- Chemical Name:sofosBuvir impurity 49
- CAS:
- MF:
- Chemical Name:SofosBuvir Impurity 55
- CAS:
- MF:
- Structure:

- Chemical Name:Tenofovir Impurity W
- CAS:1244022-55-6
- MF:C15H24N5O8P
- Chemical Name:TerButaline Ep Impurity B
- CAS:
- MF:
- Structure:

- Chemical Name:Timolol EP Impurity H
- CAS:158636-97-6
- MF:C13H24N4O3S
- Chemical Name:Tirofiban Impurity 11
- CAS:
- MF:
- Structure:

- Chemical Name:Tofacitinib Impurity 45
- CAS:2407039-29-4
- MF:C16H20N6O2
- Chemical Name:Tofacitinib impurity S
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 25
- CAS:
- MF:
- Structure:

- Chemical Name:Valaciclovir EP Impurity H
- CAS:84499-64-9
- MF:C11H16N6O4
- Structure:

- Chemical Name:Lidocaine EP Impurity F
- CAS:142713-08-4
- MF:C14H22N2O
- Chemical Name:Ampicillin Impurity P
- CAS:
- MF:
- Chemical Name:Cefdinir Impurity B (CP)
- CAS:
- MF:
- Chemical Name:Cloxacillin Impurity A
- CAS:
- MF:
- Structure:

- Chemical Name:Erythromycin Impurity E(EP)
- CAS:857839-61-3
- MF:C37H65NO12
- Structure:

- Chemical Name:Meropenem Trihydrate Impurity B
- CAS:166901-45-7
- MF:C34H50N6O10S2
- Structure:

- Chemical Name:Oxacillin Sodium Impurity D(EP)
- CAS:1642559-63-4
- MF:C18H21N3O4S
- Chemical Name:Oxacillin Sodium Impurity J(EP)
- CAS:
- MF:
- Chemical Name:Spectinomycin Impurity A
- CAS:
- MF:
- Structure:

- Chemical Name:2,7-Dimethyl-1,4-dihydroxynaphthalene 1-O-glucoside
- CAS:839711-70-5
- MF:C18H22O7
- Structure:

- Chemical Name:Eriodictyol-6-glucoside
- CAS:118040-45-2
- MF:C21H22O11
- Structure:

- Chemical Name:Rubrofusarin triglucoside
- CAS:245724-07-6
- MF:C33H42O20
- Structure:

- Chemical Name:Gabapentin EP Impurity G
- CAS:1500558-49-5
- MF:C10H19NO2
- Structure:

- Chemical Name:2-butyrylbenzoic acid
- CAS:19666-03-6
- MF:C11H12O3
- Chemical Name:Cefminox sodium impurities D
- CAS:
- MF:
- Structure:

- Chemical Name:(R)-5-chloro-N-(4-(3-oxomorpholino)phenyl)-N- ((2-oxooxazolidin-5-yl)methyl)thiophene-2-carboxamide
- CAS:1879903-65-7
- MF:C19H18ClN3O5S
- Structure:

- Chemical Name:Cefmetazole impurity
- CAS:56796-19-1
- MF:C28H27N7O5S3
- Structure:

- Chemical Name:3-ethylisobenzofuran-1(3H)-one
- CAS:17475-41-1
- MF:C10H10O2
- Structure:

- Chemical Name:Ivabradine Impurity 21 HCl
- CAS:304465-03-0
- MF:C26H34N2O5
- Chemical Name:Moxifloxacin EP Impurity C HCl
- CAS:
- MF:
- Structure:

- Chemical Name:Moxifloxacin Impurity 23
- CAS:855661-74-4
- MF:C21H24FN3O4
- Structure:

- Chemical Name:Solifenacin Related Compound 18
- CAS:1225338-27-1
- MF:C23H26N2O2
- Structure:

- Chemical Name:N-(2-hydroxy-3-(4-((2-isopropoxyethoxy)methyl)phenoxy)propyl) -N-isopropylformamide
- CAS:1447715-45-8
- MF:C19H31NO5
- Structure:

- Chemical Name:Tofacitinib Related Compound
- CAS:1206824-85-2
- MF:C10H18ClN3O