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:Enrofloxacin Impurity 1
- CAS:1128234-60-5
- MF:C19H22ClN3O3
- Chemical Name:Peramivir Impurity 20
- CAS:
- MF:
- Structure:
- Chemical Name:Ambroxol Impurity 33
- CAS:199472-91-8
- MF:C13H20N2O
- Structure:
- Chemical Name:Bilastine Impurity 12
- CAS:1638785-18-8
- MF:C30H42N4O3
- Structure:
- Chemical Name:Tadalafil Impurity 66
- CAS:1598416-07-9
- MF:C21H18N2O5
- Chemical Name:Peramivir Impurity 36
- CAS:
- MF:
- Structure:
- Chemical Name:Anastrozole EP Impurity I
- CAS:120511-91-3
- MF:C15H17ClN2
- Structure:
- Chemical Name:Anastrozole EP Impurity I
- CAS:120511-91-3
- MF:C15H17ClN2
- Structure:
- Chemical Name:(2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester
- CAS:389128-28-3
- MF:C18H26N2O5S
- Chemical Name:Everolimus impurity F
- CAS:
- MF:
- Chemical Name:Ceftriaxone Sodium impurity 4
- CAS:
- MF:
- Chemical Name:Sugammadex sodium Hepta-Iodine Impurity
- CAS:
- MF:
- Chemical Name:Abitrone project impurity
- CAS:
- MF:
- Structure:
- Chemical Name:105981-34-8
- CAS:105981-34-8
- MF:C15H22N4S
- Structure:
- Chemical Name:1364671-52-2
- CAS:1364671-52-2
- MF:C19H19ClN6O3S
- Structure:
- Chemical Name:1627504-43-1
- CAS:1627504-43-1
- MF:C14H14ClN7
- Chemical Name:Pramipexole Impurity Q
- CAS:
- MF:
- Structure:
- Chemical Name:Aprepitant Impurity 42
- CAS:172678-47-6
- MF:C20H18F7NO2
- Structure:
- Chemical Name:MILRINONE RELATED COMPOUND A (50 MG) (1,6-DIHYDRO-2-METHYL-6-OXO(3,4'-BIPYRIDINE)-5-CAR-BOXAMIDE)
- CAS:80047-24-1
- MF:C12H11N3O2
- Structure:
- Chemical Name:3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers)
- CAS:30078-48-9
- MF:C19H20N2O3
- Structure:
- Chemical Name:Efinaconazole Related Impurity 13
- CAS:2055912-03-1
- MF:C24H32FN5O
- Chemical Name:DexMedetoMidine IMpurity 17
- CAS:
- MF:
- Structure:
- Chemical Name:Sofosbuvir IMpurity 21
- CAS:2138483-01-7
- MF:C17H17FN2O6
- Chemical Name:Moxifloxacin Impurity 1
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 22
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity F
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 4
- CAS:
- MF:
- Chemical Name:Fudosteine Impurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Sugammadex Impurity 17
- CAS:2414905-36-3
- MF:C82H120NaO48PS7
- Chemical Name:Apixaban Impurity 28
- CAS:2208275-54-9
- MF:
- Structure:
- Chemical Name:Fluvastatin EP Impurity E
- CAS:
- MF:C24H26FNO4
- Chemical Name:Oseltamivir Impurity 24
- CAS:
- MF:
- Structure:
- Chemical Name:(3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate)
- CAS:
- MF:C38H38F2N2O5
- Chemical Name:Nettopitan impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Afatinib Impurity 74
- CAS:1259015-90-1
- MF:C7H13NO2
- Structure:
- Chemical Name:Afatinib Impurity 74
- CAS:1259015-90-1
- MF:C7H13NO2
- Chemical Name:Afatinib Impurity 78
- CAS:
- MF:
- Chemical Name:Afatinib Impurity 78
- CAS:
- MF:
- Structure:
- Chemical Name:Cabozantinib Impurity 47
- CAS:113136-79-1
- MF:C11H10ClNO3
- Chemical Name:Landiolol impurity Q
- CAS:
- MF:
- Chemical Name:Tenofovir Impurity 72
- CAS:
- MF:
- Structure:
- Chemical Name:Medetomidine Impurity 52
- CAS:128366-51-8
- MF:C13H14N2O2
- Chemical Name:Org246653-1(RRT0.31)
- CAS:
- MF:
- Chemical Name:Linagliptin impurity
- CAS:
- MF:
- Structure:
- Chemical Name:CEFMETAZOLE IMPURITY
- CAS:76952-82-4
- MF:C13H16N6O5S3
- Chemical Name:Acyclovir impurity R
- CAS:
- MF:
- Structure:
- Chemical Name:Ornidazole Impurity 7
- CAS:109620-80-6
- MF:C6H8ClN3O3
- Chemical Name:(1R,2S,5aS,6aS,7aR,8aS,10aS)
- CAS:
- MF:
- Chemical Name:(E)-8-(3,4-dihydroxystyryl)
- CAS:
- MF:
- Chemical Name:N,N'-((2Z,2'Z)-disulfanediylbis
- CAS:
- MF:
- Structure:
- Chemical Name:Cabozantinib impurity 1DYH
- CAS:1621681-63-7
- MF:C28H24FN3O6
- Structure:
- Chemical Name:1-((2R,3R)-3-(2,3-dihydrobenzo[b]
- CAS:2137145-62-9
- MF:C23H36N2O5
- Structure:
- Chemical Name:Tiotropium Bromide Impurity 1
- CAS:2109037-83-2
- MF:C18H20ClNO4S2
- Chemical Name:Dofetilide Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:3-pentylisoindolin-1-one
- CAS:691863-84-0
- MF:C13H17NO
- Structure:
- Chemical Name:(1R,3R)-2-acetyl-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro- 1H-pyrido[3,4-b]indole-3-carboxylate
- CAS:1598416-05-7
- MF:C22H20N2O5
- Structure:
- Chemical Name:1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N- ((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl) methyl)-N-methylmethanamine hydrochloride
- CAS:
- MF:C33H28ClF2N5O4S2
- Structure:
- Chemical Name:Labetalol EP impurity D
- CAS:32780-65-7
- MF:C9H13ClN2O3
- Structure:
- Chemical Name:ethyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate
- CAS:625115-53-9
- MF:C21H21FN8O2
- Structure:
- Chemical Name:2-[(4-CHLORO-2-NITROPHENYL)AMINO]-BENZOIC ACID
- CAS:60091-87-4
- MF:C13H9ClN2O4
- Chemical Name:Fulvestrant impurity I
- CAS:
- MF:
- Structure:
- Chemical Name:Emtricitabine
- CAS:61548-81-0
- MF:C11H22O3S
- Structure:
- Chemical Name:tert-butyl 4-(3-nitropyridin-4-yl)piperazine-1-carboxylate
- CAS:608142-93-4
- MF:C14H20N4O4
- Structure:
- Chemical Name:FEXOFENADINE, METHYL ESTER
- CAS:154825-96-4
- MF:C33H41NO4
- Chemical Name:Bendamustine Related Impurity 21
- CAS:
- MF:
- Chemical Name:Bendamustine Related Impurity 8
- CAS:
- MF:
- Chemical Name:Bortezomib Impurity 33
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 31
- CAS:
- MF:
- Chemical Name:Pitavastatin Impurity 7
- CAS:
- MF:
- Structure:
- Chemical Name:Prednisolone Impurity A
- CAS:77017-17-5
- MF:C21H26O5
- Structure:
- Chemical Name:Rivaroxaban Impurity 61
- CAS:1643354-27-1
- MF:C32H30N4O8
- Chemical Name:Rivaroxaban Impurity 74
- CAS:
- MF:
- Chemical Name:Sitafloxacin Impurity 6
- CAS:
- MF:
- Chemical Name:Ticagrelor Related Compound 75
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Related Compound 93
- CAS:2207528-55-8
- MF:C23H28F2N6O4S
- Structure:
- Chemical Name:Vonoprazan Impurity 24
- CAS:1807642-41-6
- MF:C16H14FN3O2S
- Chemical Name:Vonoprazan Impurity 35
- CAS:
- MF:
- Chemical Name:Adefovir Impurity 2
- CAS:
- MF:
- Chemical Name:Avibactam Impurity R
- CAS:
- MF:
- Chemical Name:Blonanserin Impurity L
- CAS:
- MF:
- Chemical Name:Cefazolin USP Impurity E
- CAS:
- MF:
- Chemical Name:Exemestane Impurity 5
- CAS:
- MF:
- Structure:
- Chemical Name:Medetomidine Impurity 28
- CAS:2240179-64-8
- MF:C23H28N2
- Structure:
- Chemical Name:Peramivir Impurity 4
- CAS:229615-12-7
- MF:C15H28N4O4
- Chemical Name:Sugammadex disulfide Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Hispidulin 4'-O-β-D-glucopyranoside
- CAS:244285-12-9
- MF:C22H22O11
- Chemical Name:Dexmedetomidine Impurity 19
- CAS:
- MF:
- Structure:
- Chemical Name:Voriconazole Impurity 18
- CAS:321588-94-7
- MF:C22H18ClF4N7O
- Structure:
- Chemical Name:Remdesivir impurity
- CAS:1911578-74-9
- MF:C12H14N5O7P
- Structure:
- Chemical Name:ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate
- CAS:616201-27-5
- MF:C38H43FN2O5
- Chemical Name:Peramivir Impurity 16
- CAS:
- MF:
- Structure:
- Chemical Name:Tiotropium bromide Impurity 13
- CAS:1459721-06-2
- MF:C18H19NO4S2
- Chemical Name:Anastrozole Impurity I
- CAS:
- MF:
- Chemical Name:Anastrozole Impurity I
- CAS:
- MF:
- Chemical Name:Fluconazole impurity I(For Chinese Pharmacopiea)
- CAS:
- MF:
- Structure:
- Chemical Name:Rocuronium bromide diepoxide impurity
- CAS:
- MF:C21H30O4
- Chemical Name:2-hydroxy-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile
- CAS:
- MF:
- Structure:
- Chemical Name:6-Methoxykaempferol 3-O-glucoside
- CAS:63422-27-5
- MF:C22H22O12
- Chemical Name:Topiroxostat Impurity 39
- CAS:
- MF:
- Chemical Name:Vonoprazan Impurity 60
- CAS:
- MF: