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.
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- Structure:
- Chemical Name:
- Dapagliflozin Open Ring
- CAS:
- 2100872-88-4
- MF:
- C21H27ClO7
- Chemical Name:
- Rortezide impurity
- Chemical Name:
- Aprepitant Impurity 2
- Chemical Name:
- Cabozantinib Impurity A
- Chemical Name:
- Loxoprofen Impurity E
- Structure:
- Chemical Name:
- (R)-4-Propylpyrrolidin-2-one
- CAS:
- 930123-37-8
- MF:
- C7H13NO
- Structure:
- Chemical Name:
- Rocuronium Bromide Intermediate B Impurity E-1
- CAS:
- 1190105-60-2
- MF:
- C29H48N2O3
- Structure:
- Chemical Name:
- 4-Chloro-2-propylsulfanyl-pyrimidine
- CAS:
- 1351990-36-7
- MF:
- C7H9ClN2S
- Structure:
- Chemical Name:
- benzyl (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoate
- CAS:
- 1194550-67-8
- MF:
- C36H30Cl2N2O7S
- Structure:
- Chemical Name:
- D-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]-
- CAS:
- 119238-52-7
- MF:
- C9H15NO3S
- Structure:
- Chemical Name:
- 2,4(1H,3H)-Pyrimidinedione,5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2S-cis)- (9CI)
- CAS:
- 145281-92-1
- MF:
- C8H9FN2O4S
- Structure:
- Chemical Name:
- Cyclopentanecarboxylic acid, 1-[(1-oxopentyl)amino]-
- CAS:
- 15026-80-9
- MF:
- C11H19NO3
- Structure:
- Chemical Name:
- L-Phenylalanine, N-L-leucyl-, methyl ester
- CAS:
- 38155-18-9
- MF:
- C16H24N2O3
- Structure:
- Chemical Name:
- Ethanol, 2-[(2-chloroethyl)amino]-
- CAS:
- 3890-98-0
- MF:
- C4H10ClNO
- Structure:
- Chemical Name:
- 5-Methylarabinosylcytosine
- CAS:
- 6829-31-8
- MF:
- C10H15N3O5
- Structure:
- Chemical Name:
- Anthranilic acid, N-furfuryl-5-sulfamoyl-
- CAS:
- 4818-85-3
- MF:
- C12H12N2O5S
- Structure:
- Chemical Name:
- 1,3-Benzodioxol-4-ol
- CAS:
- 69393-72-2
- MF:
- C7H6O3
- Structure:
- Chemical Name:
- 1H-Benzimidazole, 6-bromo-2-methyl-4-(phenylmethoxy)-
- CAS:
- 774582-60-4
- MF:
- C15H13BrN2O
- Structure:
- Chemical Name:
- (Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methyl)ethoxyiminoacetic acid
- CAS:
- 102507-85-7
- MF:
- C9H11N3O5S
- Chemical Name:
- Cefaclor EP IMpurity
- Structure:
- Chemical Name:
- Alogliptin Impurity B
- CAS:
- 865758-98-1
- MF:
- C17H19N5O2
- Structure:
- Chemical Name:
- Linagliptin Impurity F
- CAS:
- 1673546-62-7
- MF:
- C27H27F3N8O3
- Chemical Name:
- Parecoxib Impurity D
- Chemical Name:
- Parecoxib Impurity I
- Structure:
- Chemical Name:
- 1-Hydroxymethyl-beta-carboline glucoside
- CAS:
- 1408311-12-5
- MF:
- C18H20N2O6
- Structure:
- Chemical Name:
- Axitinib Impurity D
- CAS:
- 1443118-72-6
- MF:
- C29H25N5OS
- Structure:
- Chemical Name:
- Lenvatinib Impurity d
- CAS:
- 417717-04-5
- MF:
- C20H17ClN4O4
- Structure:
- Chemical Name:
- 4-bromo-3-(hydroxymethyl)phenol
- CAS:
- 2737-20-4
- MF:
- C7H7BrO2
- Structure:
- Chemical Name:
- 4-(4-Bromo-3-formyl-phenoxy)-benzonitrile
- CAS:
- 906673-54-9
- MF:
- C14H8BrNO2
- Chemical Name:
- Atracurium Impurity E
- Chemical Name:
- Linagliptin Impurity I
- Structure:
- Chemical Name:
- 1H-Pyrrole-3-carbonitrile,5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)-
- CAS:
- 1807642-39-2
- MF:
- C16H10FN3O2S
- Structure:
- Chemical Name:
- 4-amino-1-[(2RS)-2-(2,4-difluorophenyl)-2-hydroxy-3(1H- 1,2,4-triazol-1-yl)propyl]-4H-1,2,4-triazolium
- CAS:
- 749821-19-0
- MF:
- C13H14F2N7O+
- Chemical Name:
- Canagliflozin Defluoro Impurity
- Chemical Name:
- Dapagliflozin Impurity 6
- Structure:
- Chemical Name:
- Imatinib Impurity 7
- CAS:
- 581076-64-4
- MF:
- C8H12N4
- Structure:
- Chemical Name:
- Nilotinib Impurity 1
- CAS:
- 641571-05-3
- MF:
- C28H22F3N7O
- Chemical Name:
- Riociguat Impurtiy 1
- Structure:
- Chemical Name:
- Riociguat Impurtiy 6
- CAS:
- 1702271-98-4
- MF:
- C18H17FN8
- Structure:
- Chemical Name:
- Axitinib Impurity 4
- CAS:
- 1443118-73-7
- MF:
- C22H20N4OS
- Structure:
- Chemical Name:
- Brimonidine Impurity E
- CAS:
- 168329-48-4
- MF:
- C9H8BrN5
- Chemical Name:
- Dapagliflozin Impurity G
- Chemical Name:
- Dapoxetine Impurity B
- Chemical Name:
- Esomeprazole EP Impurity
- Structure:
- Chemical Name:
- Fesoterodine Diol Dimer
- CAS:
- 1428856-45-4
- MF:
- C44H60N2O3
- Structure:
- Chemical Name:
- Gimeracil Impurity
- CAS:
- 17902-24-8
- MF:
- C8H9ClN2O3
- Chemical Name:
- Pramipexole Impurity H
- Structure:
- Chemical Name:
- Quercetin 3-rutinoside 7-glucoside
- CAS:
- 30311-61-6
- MF:
- C33H40O21
- Structure:
- Chemical Name:
- Rivaroxaban Impurity H
- CAS:
- 1807455-76-0
- MF:
- C25H24Cl2N4O6S2
- Chemical Name:
- Vonoprazan impurity A
- Structure:
- Chemical Name:
- 34-Methylcyanocobalamin
- CAS:
- 38218-51-8
- MF:
- C64H90CoN14O14P
- Chemical Name:
- Empagliflozin Impurity D
- Chemical Name:
- Ipragliflozin Impurity 2
- Chemical Name:
- Nicergoline EP impurity F
- Structure:
- Chemical Name:
- 2-Butyl-1,6-dihydro-N,N,4-trimethyl-6-oxo-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-5-pyrimidineacetamide
- CAS:
- 503155-67-7
- MF:
- C46H45N7O2
- Structure:
- Chemical Name:
- O-De(3-fluorobenzyl) Lapatinib
- CAS:
- 1268997-70-1
- MF:
- C22H21ClN4O4S
- Structure:
- Chemical Name:
- 5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethylenediol
- CAS:
- 112935-92-9
- MF:
- C14H20N2O6
- Structure:
- Chemical Name:
- Desloratadine Epoxide
- CAS:
- 1346604-23-6
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- Menaquinone 4 2,3-Epoxide
- CAS:
- 72908-86-2
- MF:
- C31H40O3
- Structure:
- Chemical Name:
- D-Phenylalanyl Nateglinide
- CAS:
- 944746-48-9
- MF:
- C28H36N2O4
- Structure:
- Chemical Name:
- Felodipine 3,5-DiMethyl Ester
- CAS:
- 91189-59-2
- MF:
- C17H17Cl2NO4
- Structure:
- Chemical Name:
- Moxifloxacin Methyl Ester
- CAS:
- 721970-35-0
- MF:
- C22H26FN3O4
- Structure:
- Chemical Name:
- Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride)
- CAS:
- 873310-31-7
- MF:
- C17H22ClNO
- Structure:
- Chemical Name:
- Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide)
- CAS:
- 176447-94-2
- MF:
- C18H25N3O5S2
- Structure:
- Chemical Name:
- Zolmitriptan Related Compound B (20 mg) ((S)-2-Amino-3-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}propan-1-ol)
- CAS:
- 139264-69-0
- MF:
- C15H23N3O
- Structure:
- Chemical Name:
- 1-BENZYL-N,4-DIMETHYLPIPERIDIN-3-AMINE DIHYDROCHLORIDE
- CAS:
- 384338-23-2
- MF:
- C14H22N2
- Structure:
- Chemical Name:
- (R,Z)-2-((R)-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)(carboxy)Methyl)-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid
- CAS:
- 178422-39-4
- MF:
- C14H15N5O6S2
- Structure:
- Chemical Name:
- Acyclovir IMpurity C
- CAS:
- 91702-61-3
- MF:
- C8H11N5O3
- Structure:
- Chemical Name:
- Nicergoline-5-Chloro Analogue
- CAS:
- 38536-28-6
- MF:
- C24H26ClN3O3
- Structure:
- Chemical Name:
- 1-(3-aMino-5-(benzyloxy)-2-hydroxyphenyl)ethanone
- CAS:
- 861841-90-9
- MF:
- C15H15NO3
- Structure:
- Chemical Name:
- (2RS)-2-Hydroxy-2-[4-(2-Methylpropyl)phenyl]propanoic Acid
- MF:
- C13H18O3
- Chemical Name:
- Mirabegron Impurity 4
- Structure:
- Chemical Name:
- Bisoprolol EP Impurity D
- CAS:
- 1225195-71-0
- MF:
- C26H40N2O5
- Structure:
- Chemical Name:
- Febuxostat Descyano Impurity
- CAS:
- 1206550-99-3
- MF:
- C15H17NO3S
- Structure:
- Chemical Name:
- (5S,8R,9S,10S,13S,14S)-10,13-dimethyl-1,5,6,7,8,9,10,11,12,13,15,16-dodecahydro-4H-cyclopenta[a]phenanthren-17(14H)-one
- CAS:
- 14639-79-3
- MF:
- C19H28O
- Structure:
- Chemical Name:
- Cefuroxime Sodium Impurity
- MF:
- C16H16N4NaO8S
- Structure:
- Chemical Name:
- 5-chloro-6-[4-(ethoxycarbonyl)piperidino]nicotinic acid
- CAS:
- 931395-73-2
- MF:
- C14H17ClN2O4
- Structure:
- Chemical Name:
- 2-Bromo (S)-Carbidopa
- CAS:
- 43197-33-7
- MF:
- C10H13BrN2O4
- Structure:
- Chemical Name:
- Eliglustat intermediate 3
- CAS:
- 491833-26-2
- MF:
- C23H28N2O5
- Structure:
- Chemical Name:
- Aztreonam Impurity B
- CAS:
- 102586-36-7
- MF:
- C13H19N5O6S
- Structure:
- Chemical Name:
- Atorvastatin Impurity 30
- CAS:
- 666714-64-3
- MF:
- C26H23FN2O
- Chemical Name:
- Olopatadine impurity
- Structure:
- Chemical Name:
- Azilsartan Impurity
- CAS:
- 1863930-34-0
- MF:
- C23H23N3O3
- Structure:
- Chemical Name:
- Voriconazole Impurity 8
- CAS:
- 239807-03-5
- MF:
- C16H14F3N5O
- Chemical Name:
- Caspofungin impurity 3
- Chemical Name:
- Plerixafor Impurity D
- Structure:
- Chemical Name:
- Cefuroxime impurity 1
- MF:
- C16H16N4O8S
- Chemical Name:
- Vonoprazan Impurity 9
- Chemical Name:
- Sitagliptin IMpurity 5
- Chemical Name:
- Brexpiprazole Impurity3
- Structure:
- Chemical Name:
- Levetiracetam impurity 5
- CAS:
- 1543300-90-8
- MF:
- C9H17NO4
- Chemical Name:
- Febuxostat Impurity B
- Chemical Name:
- Sorafenib Impurity F
- Structure:
- Chemical Name:
- Trelagliptin Impurity 1
- CAS:
- 1821400-07-0
- MF:
- C21H13ClF2N4O2
- Structure:
- Chemical Name:
- Vortioxetine Imp.J
- CAS:
- 2137588-68-0
- MF:
- C18H22N2S
- Structure:
- Chemical Name:
- 4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide
- CAS:
- 1608459-56-8
- MF:
- C18H27N3O3
- Structure:
- Chemical Name:
- 4,5-dichloro Rivaroxaban
- CAS:
- 2305917-61-5
- MF:
- C25H28ClN3O6S
- Structure:
- Chemical Name:
- Solifenacin EP Impurity B
- CAS:
- 1534326-81-2
- MF:
- C31H28N2O
- Structure:
- Chemical Name:
- Vildagliptin Impurity 6
- CAS:
- 1846606-31-2
- MF:
- C17H23N3O2
- Chemical Name:
- Flucloxacillin Impurity A