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.
Click on the specific product, view the latest prices of the products, information, serving information
- Chemical Name:
- Diquafosol Impurity C
- Chemical Name:
- Bortezomib Impurity 19
- Chemical Name:
- Apixaban Impurity 40
- Chemical Name:
- Axitinib Impurity 3
- Chemical Name:
- Sofosbuvir Impurity 10
- Structure:
- Chemical Name:
- Venlafaxine Impurity 10
- CAS:
- 1997279-63-6
- MF:
- C17H27NO2
- Chemical Name:
- Dapoxetine Impurity 3
- Chemical Name:
- Regorafenib Impurity 16
- Chemical Name:
- Topiroxostat Impurity 7
- Chemical Name:
- Tofacitinib Impurity 12
- Chemical Name:
- Ticagrelor Impurity 16
- Chemical Name:
- Ticagrelor Impurity 22
- Chemical Name:
- Milrinone Impurity 5
- Structure:
- Chemical Name:
- Caspofungin Impurity 4
- CAS:
- 258510-40-6
- MF:
- C49H78N8O17
- Chemical Name:
- Canagliflozin Impurity 27
- Chemical Name:
- Loxoprofen Impurity 1
- Chemical Name:
- Febuxostat Impurity 54
- Chemical Name:
- Silodosin Impurity B
- Structure:
- Chemical Name:
- Mirabegron iMpurity
- CAS:
- 1581285-26-8
- MF:
- C16H21ClN2
- Structure:
- Chemical Name:
- Sunitinib iMpurity
- CAS:
- 356068-98-9
- MF:
- C12H19N3O2
- Structure:
- Chemical Name:
- (-)-DihydroapovincaMinic Acid Ethyl Ester
- CAS:
- 57327-92-1
- MF:
- C22H28N2O2
- Structure:
- Chemical Name:
- (α1S,α4S,2S,5S)-2,5-DiMethyl-3,6-dioxo-α1,α4-bis(2-phenylethyl)-1,4-piperazinediacetic Acid 1,4-Diethyl Ester
- CAS:
- 151387-05-2
- MF:
- C30H38N2O6
- Structure:
- Chemical Name:
- [2-(4-Fluorophenyl)cyclopropyl]aMine hydrochloride
- CAS:
- 879324-66-0
- MF:
- C9H11ClFN
- Structure:
- Chemical Name:
- [4-(4-AMino-7-hydroxy-6-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone
- CAS:
- 105356-90-9
- MF:
- C18H23N5O4
- Structure:
- Chemical Name:
- 2-(DiethylaMino)-N-(2,5-diMethylphenyl)acetaMide Hydrochloride
- CAS:
- 1012864-23-1
- MF:
- C14H23ClN2O
- Structure:
- Chemical Name:
- 2-Keto-D-gulonic Acid Methyl Ester
- CAS:
- 67776-07-2
- MF:
- C7H12O7
- Structure:
- Chemical Name:
- 9,11-Dehydro-17α-cyanoMethyl Estradiol
- CAS:
- 86153-38-0
- MF:
- C20H23NO2
- Structure:
- Chemical Name:
- DeMethyl Irbesartan
- CAS:
- 158778-58-6
- MF:
- C24H26N6O
- Structure:
- Chemical Name:
- Epiprednisolone
- CAS:
- 600-90-8
- MF:
- C21H28O5
- Structure:
- Chemical Name:
- δ-2-CefodiziMe (2 :1 Mixture)
- CAS:
- 120533-30-4
- MF:
- C20H20N6O7S4
- Structure:
- Chemical Name:
- Salbutamol Acetonide
- CAS:
- 54208-72-9
- MF:
- C16H25NO3
- Structure:
- Chemical Name:
- Salbutamol Acetonide
- CAS:
- 54208-72-9
- MF:
- C16H25NO3
- Structure:
- Chemical Name:
- 8-Chloro-1-methyl-6-phenyl-4H-Imidazo[1,5-a][1,4]benzodiazepine
- CAS:
- 59467-86-6
- MF:
- C18H14ClN3
- Structure:
- Chemical Name:
- BenzeneMethanaMine, 4-ethoxy-3-Methoxy-a-[(Methylsulfonyl)Methyl]-
- CAS:
- 885268-06-4
- MF:
- C12H19NO4S
- Chemical Name:
- Afatinib IMpurity C
- Structure:
- Chemical Name:
- AMisulpride IMpurity
- CAS:
- 84859-26-7
- MF:
- C8H17NO2
- Chemical Name:
- Avanafil iMpurity 5
- Chemical Name:
- Cefoxitin iMpurity E (R-Methoxy cefoxitin)
- Structure:
- Chemical Name:
- Desloratadine IMpurity 3
- CAS:
- 1346600-61-0
- MF:
- C19H19ClN2
- Structure:
- Chemical Name:
- DibroMo IMpurity
- CAS:
- 1352492-08-0
- MF:
- C15H12Br2O2
- Structure:
- Chemical Name:
- ErtapeneM IMpurity DIPP
- CAS:
- 220031-86-7
- MF:
- C18H27N2O6PS
- Structure:
- Chemical Name:
- Gefitinib IMpurity 1
- CAS:
- 1561173-24-7
- MF:
- C15H22ClN3O3
- Structure:
- Chemical Name:
- Pitavastatin Defuoro IMpurity CalciuM Salt
- CAS:
- 1258947-30-6
- MF:
- C50H50CaN2O8
- Structure:
- Chemical Name:
- Solifenacin Related CoMpound 4 Succinate
- CAS:
- 862207-71-4
- MF:
- C27H32N2O6
- Structure:
- Chemical Name:
- TenoxicaM IMpurity E (2-Methylthieno[2,3-d]isothiazol-3(2H)-one-1,1-dioxide )
- CAS:
- 94040-09-2
- MF:
- C6H5NO3S2
- Structure:
- Chemical Name:
- (+)-(14β)-Dihydrovinpocetine
- CAS:
- 57517-54-1
- MF:
- C22H28N2O2
- Structure:
- Chemical Name:
- D,L-Venlafaxine-d10 Hydrochloride
- CAS:
- 1216539-56-8
- MF:
- C17H28ClNO2
- Chemical Name:
- Cefminox Sodium impurity F
- Chemical Name:
- Clindamycin Impurity F
- Chemical Name:
- Fasudil iMpurity D
- Structure:
- Chemical Name:
- 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)acetic acid
- CAS:
- 929540-41-0
- MF:
- C36H41CaFN2O5
- Chemical Name:
- Doxofylline iMpurity C
- Structure:
- Chemical Name:
- Puerarin-4'-O-β-D-glucopyranoside
- CAS:
- 117047-08-2
- MF:
- C27H30O14
- Structure:
- Chemical Name:
- N-Propyl-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one
- CAS:
- 2512208-76-1
- MF:
- C15H21NO3
- Structure:
- Chemical Name:
- Flurbiprofen Impurity
- CAS:
- 64858-90-8
- MF:
- C17H17FO2
- Structure:
- Chemical Name:
- the Metabolite of Ivabradine
- CAS:
- 215935-23-2
- MF:
- C26H34N2O5
- Structure:
- Chemical Name:
- Acarbose 1,1-α,α-Glycoside IMpurity
- CAS:
- 610271-07-3
- MF:
- C25H43NO18
- Structure:
- Chemical Name:
- Des-6-[4-(2-hydroxyethyl)-1-piperazinyl]-6-chloro Dasatinib
- CAS:
- 910297-71-1
- MF:
- C16H13Cl2N5O2S
- Structure:
- Chemical Name:
- Hydroxythiovardenafil
- CAS:
- 912576-30-8
- MF:
- C23H32N6O4S2
- Structure:
- Chemical Name:
- (((((1-(6-aMino-9H-purin-9-yl)propan-2-yl)oxy)Methyl)phosphoryl)bis(oxy))bis(Methylene) isopropyl Methyl dicarbonate
- CAS:
- 1246812-43-0
- MF:
- C17H26N5O10P
- Structure:
- Chemical Name:
- 9(10H)-Acridinone, 6-aMino-2-ethoxy-
- CAS:
- 144335-20-6
- MF:
- C15H14N2O2
- Chemical Name:
- parecoxib impurity L
- Structure:
- Chemical Name:
- Rupatadine iMpurity
- CAS:
- 169253-15-0
- MF:
- C19H19ClN2
- Chemical Name:
- ceftazidiMe iMpurity C
- Structure:
- Chemical Name:
- pidotiMod iMpurity E
- CAS:
- 162148-16-5
- MF:
- C9H12N2O4S
- Structure:
- Chemical Name:
- 1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-[7-(hydroxyMethyl)-7H-pyrrolo[2,3-d]pyriMidin-4-yl]-,(βR)-
- CAS:
- 1236033-03-6
- MF:
- C18H20N6O
- Structure:
- Chemical Name:
- Cyclopropanecarboxylic acid, 1-[(phenylaMino)carbonyl]-
- CAS:
- 145591-80-6
- MF:
- C11H11NO3
- Structure:
- Chemical Name:
- 3-PiperidinaMine, 1-acetyl-N,4-diMethyl-N-1H-pyrrolo[2,3-d]pyriMidin-4-yl-, (3R,4R)- (9CI)
- CAS:
- 477600-76-3
- MF:
- C15H21N5O
- Structure:
- Chemical Name:
- AzithroMycin iMpurity
- CAS:
- 194809-66-0
- MF:
- C37H69BN2O13
- Structure:
- Chemical Name:
- MeropeneM iMpurity
- CAS:
- 96035-23-3
- MF:
- C15H19N3O5S
- Structure:
- Chemical Name:
- Ciprofloxacin EP IMpurity B
- CAS:
- 93107-11-0
- MF:
- C17H19N3O3
- Structure:
- Chemical Name:
- Valdecoxib IMpurity-E
- CAS:
- 1373038-63-1
- MF:
- C16H11Cl2NO5S2
- Structure:
- Chemical Name:
- Sunitinib N-Oxide
- CAS:
- 356068-99-0
- MF:
- C22H27FN4O3
- Structure:
- Chemical Name:
- Abiraterone Sulfate
- Chemical Name:
- AtracuriuM IMpurity G (R-Laudanosine)
- Chemical Name:
- BendaMustine IMpurity D BendaMustine N-Alkylated IMpurity
- Chemical Name:
- Cefradine IMpurity E
- Structure:
- Chemical Name:
- Cetirizine IMpurity-7
- MF:
- C21H25ClN2O3
- Chemical Name:
- Dasatinib IMpurity 6
- Structure:
- Chemical Name:
- Desacetyl CefathiaMidine
- CAS:
- 958001-61-1
- MF:
- C17H26N4O5S2
- Structure:
- Chemical Name:
- Fluconazole IMpurity D
- MF:
- C13H12F2N6O
- Structure:
- Chemical Name:
- Lercanidipine IMpurity A
- CAS:
- 74936-74-6
- MF:
- C19H22N2O6
- Structure:
- Chemical Name:
- Loratadine 2-Chloro IMpurity
- CAS:
- 165739-64-0
- MF:
- C22H22Cl2N2O2
- Structure:
- Chemical Name:
- Metoprolol IMpurity F
- MF:
- C15H25NO3
- Structure:
- Chemical Name:
- Miconazole IMpurity I
- CAS:
- 47363-37-1
- MF:
- C18H15Cl3N2O
- Chemical Name:
- Milrinone IMpurity 1
- Structure:
- Chemical Name:
- Nicardipine Related CoMpound 2
- CAS:
- 64603-72-1
- MF:
- C16H14N2O6
- Structure:
- Chemical Name:
- Saxagliptin IMpurity 1
- CAS:
- 1564266-73-4
- MF:
- C6H10N2O
- Structure:
- Chemical Name:
- Sitagliptin DeaMino IMpurity 1
- CAS:
- 1253056-18-6
- MF:
- C16H12F6N4O
- Structure:
- Chemical Name:
- Sitagliptin Defuoro IMpurity 5
- CAS:
- 486460-31-5
- MF:
- C16H16F5N5O
- Structure:
- Chemical Name:
- TiMolol IMpurity E
- CAS:
- 1026075-53-5
- MF:
- C17H26N4O6S
- Structure:
- Chemical Name:
- EthanediaMide iMpurity J
- MF:
- C2H4N2O2
- Structure:
- Chemical Name:
- 4,6-dichloro-2-(propylthio)pyriMidine
- CAS:
- 1401318-10-2
- MF:
- C7H8Cl2N2S
- Chemical Name:
- Istradefylline impurity B
- Structure:
- Chemical Name:
- Ticagrelor diastereoMer
- CAS:
- 1459719-81-3
- MF:
- C9H9F2N
- Chemical Name:
- Ceritinib IMpurity
- Chemical Name:
- Melphalan IMpurity
- Structure:
- Chemical Name:
- 1-[2-[(5-chloro-2,4-diMethylphenyl)thio]phenyl]- Piperazine
- CAS:
- 1240670-87-4
- MF:
- C18H21ClN2S
- Structure:
- Chemical Name:
- LCZ Impurity
- CAS:
- 753421-85-1
- MF:
- C20H25NO2