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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- Chemical Name:
- Pregabalin Impurity 25
- Structure:
- Chemical Name:
- Loxoprofen
- CAS:
- 50882-18-3
- MF:
- C7H10O3
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1543937-58-1
- MF:
- C13H16N2O3
- Structure:
- Chemical Name:
- Mono Oxidation Sugammadex(Org198958-2)
- CAS:
- 2412953-13-8
- MF:
- C72H113NaO49S8
- Structure:
- Chemical Name:
- 3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene)
- MF:
- C20H26O
- Structure:
- Chemical Name:
- (S)-2-(BENZYLOXY)PROPIONAL
- CAS:
- 81445-44-5
- MF:
- C10H12O2
- Structure:
- Chemical Name:
- 1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene
- CAS:
- 1662702-90-0
- MF:
- C15H15ClO
- Structure:
- Chemical Name:
- Mupirocin iMpurity F
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Palbociclib Impurity 87
- CAS:
- 571189-51-0
- MF:
- C25H31N7O2
- Chemical Name:
- Beclometasone Impurity U
- Structure:
- Chemical Name:
- Atracurium Impurity 15 Iodide（Cisatracurium Besilate EP Impurity O Iodide）
- CAS:
- 155913-31-8
- MF:
- C38H49NO11S
- Structure:
- Chemical Name:
- Vortioxetine Impurity 29
- CAS:
- 1928741-88-1
- MF:
- C18H23ClN2S
- Structure:
- Chemical Name:
- Neratinib Impurity 12
- CAS:
- 544417-27-8
- MF:
- C33H37ClN6O3
- Chemical Name:
- Ceftriaxone Sodium impurity 2
- Structure:
- Chemical Name:
- Enrofloxacin EP Impurity E
- CAS:
- 1369495-59-9
- MF:
- C19H22ClN3O3
- Structure:
- Chemical Name:
- 147027-08-5
- CAS:
- 147027-08-5
- MF:
- C14H24O4S
- Structure:
- Chemical Name:
- Cloxacillin EP Impurity A
- CAS:
- 1642629-96-6
- MF:
- C19H20ClN3O6S
- Structure:
- Chemical Name:
- Entacapone Impurity 7
- CAS:
- 1215039-66-9
- MF:
- C12H10N2O6
- Structure:
- Chemical Name:
- 4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide
- CAS:
- 150727-06-3
- MF:
- C25H24ClN5O4S
- Structure:
- Chemical Name:
- 1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride
- CAS:
- 267241-20-3
- MF:
- C24H37ClN4
- Structure:
- Chemical Name:
- (3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine)
- MF:
- C26H34F2N2O
- Chemical Name:
- DexMedetoMidine IMpurity 15
- Chemical Name:
- Canagliflozin Impurity 1
- Chemical Name:
- Vonoprazan Impurity 24
- Chemical Name:
- Esomeprazole Impurity
- Chemical Name:
- Esomeprazole Impurity 27
- Structure:
- Chemical Name:
- Amlodipine Impurity 30
- CAS:
- 1089674-39-4
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Alogliptin Impurity 30
- Chemical Name:
- Orlistat Impurity 16
- Chemical Name:
- Olaparib Impurity 27
- Structure:
- Chemical Name:
- Hydrocortisone Impurity 14
- MF:
- C21H30O5
- Chemical Name:
- Teneligliptin Impurity 5
- Chemical Name:
- Erlotinib Hydrochloride iMpurity 54
- Chemical Name:
- Aciclovir EP Impurity N
- Chemical Name:
- Vonoprazan Impurity U2
- Chemical Name:
- Parecoxib SodiuM iMpurity 36
- Structure:
- Chemical Name:
- phenyl (3R,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate compound
- CAS:
- 105812-85-9
- MF:
- C26H24FNO5
- Chemical Name:
- Apixaban Impurity A25
- Chemical Name:
- Trelagliptin IMpurity 32
- Structure:
- Chemical Name:
- Afatinib Impurity 77
- CAS:
- 26404-20-6
- MF:
- C5H7ClO3
- Structure:
- Chemical Name:
- 2a,3a,16a,17a-Diepoxy-17b-acetoxy-5a-androstane
- CAS:
- 50588-22-2
- MF:
- C21H30O4
- Structure:
- Chemical Name:
- bis(6-(((3S,4R)-4-(4-fluorophenyl)piperidin-3-yl)methoxy)benzo[d][1,3]dioxol-5-yl)methane
- CAS:
- 2105932-71-4
- MF:
- C39H40F2N2O6
- Chemical Name:
- Tenofovir Impurity 60
- Structure:
- Chemical Name:
- ((3R,4S)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate
- CAS:
- 1258537-32-4
- MF:
- C20H24FNO3S
- Structure:
- Chemical Name:
- Mupirocin Calcium EP Impurity H
- MF:
- C26H44CaO9
- Structure:
- Chemical Name:
- Tricyclo[3.3.1.13,7]decane-1,3-diol, 5-amino-
- CAS:
- 1382839-19-1
- MF:
- C10H17NO2
- Structure:
- Chemical Name:
- (trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- methoxyphenyl)piperidine-1-carboxylate
- MF:
- C27H27NO6
- Structure:
- Chemical Name:
- Org198786-1
- CAS:
- 2412952-96-4
- MF:
- C71H114NNaO46S7
- Structure:
- Chemical Name:
- 2-Thiazolamine, 4-(4-bromo-2-thienyl)-
- CAS:
- 81216-89-9
- MF:
- C7H5BrN2S2
- Chemical Name:
- Edaravone Impurity
- Structure:
- Chemical Name:
- 1-Butanesulfonic acid, 4-hydroxy-, methyl ester
- CAS:
- 343928-18-7
- MF:
- C5H12O4S
- Chemical Name:
- Fesoterodine Impurity 17
- Structure:
- Chemical Name:
- 1-(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1-oxide
- MF:
- C28H54N8O
- Structure:
- Chemical Name:
- Cabozantinib impurity DX2
- CAS:
- 1628530-38-0
- MF:
- C28H24FN3O6
- Structure:
- Chemical Name:
- Elagolix Sodium impurity4
- CAS:
- 2248628-92-2
- MF:
- C19H21NO4S
- Chemical Name:
- Tadalafil Impurity 45
- Structure:
- Chemical Name:
- (R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol
- MF:
- C28H28O3
- Structure:
- Chemical Name:
- (trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O
- Chemical Name:
- Selegiline Impurity (224Da)
- Chemical Name:
- Oxybutynin Impurity(MW 481Da)
- Chemical Name:
- Vitamin K1 hydroxylated Impurity
- Chemical Name:
- 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid 4HCl
- Chemical Name:
- Cefdinir CP Impurity F
- Chemical Name:
- Ceftazidime Oxide Impurity 1
- Chemical Name:
- Nifuratel Impurity 21
- Structure:
- Chemical Name:
- Ornidazole Impurity 15
- CAS:
- 105687-87-4
- MF:
- C7H9ClN4O5
- Structure:
- Chemical Name:
- 2-(Dimethylamino)ethyl 4-methylbenzenesulfonate
- CAS:
- 123091-15-6
- MF:
- C11H17NO3S
- Structure:
- Chemical Name:
- Vildagliptin I Impurity
- CAS:
- 1811569-16-0
- MF:
- C7H9IN2O
- Structure:
- Chemical Name:
- Acemetacin EP Impurity D/6-t-Butyl Acemetacin/[[[1-(4-Chlorobenzoyl)-6-(1,1-dimethylethyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetic acid
- CAS:
- 76812-64-1
- MF:
- C25H26ClNO6
- Structure:
- Chemical Name:
- Pregabalin Impurity 38
- CAS:
- 1141362-94-8
- MF:
- C8H15NO2
- Chemical Name:
- Acemetacin Impurity Ｄ
- Chemical Name:
- 6,6'-oxybis(3-formylbenzonitrile)
- Structure:
- Chemical Name:
- 4-乙基-2,3-二氧代-N-苯基哌嗪-1-甲酰胺
- CAS:
- 65322-79-4
- MF:
- C13H15N3O3
- Structure:
- Chemical Name:
- Cucurbitacin IIa 2-O-glucoside
- CAS:
- 77704-34-8
- MF:
- C38H60O13
- Structure:
- Chemical Name:
- Cabozantinib Impurity EXA
- CAS:
- 1431468-36-8
- MF:
- C17H14F2N2O2
- Chemical Name:
- Tafluprost Impurity 13
- Structure:
- Chemical Name:
- ISOPROMETHAZINE HYDROCHLORIDE
- CAS:
- 5568-90-1
- MF:
- C17H21ClN2S
- Structure:
- Chemical Name:
- ZOLPIDEM IMPURITY A
- CAS:
- 1346600-85-8
- MF:
- C19H21N3O
- Structure:
- Chemical Name:
- Carbamic acid, N-[(1S,2S,4S)-2-hydroxy-4-[[(2-methylpropoxy)carbonyl]amino]-5-phenyl-1-(phenylmethyl)pentyl]-, 5-thiazolylmethyl ester
- CAS:
- 1010809-39-8
- MF:
- C28H35N3O5S
- Structure:
- Chemical Name:
- Piperazine, 1,4-bis[2-[(2,4-dimethylphenyl)thio]phenyl]-
- CAS:
- 2243045-82-9
- MF:
- C32H34N2S2
- Structure:
- Chemical Name:
- 2-amino-4-methoxy-5-(3-morpholin-4-ylpropoxy)benzoic acid
- CAS:
- 1640351-46-7
- MF:
- C15H22N2O5
- Structure:
- Chemical Name:
- 3-Desoxyvitamin D3
- CAS:
- 69662-75-5
- MF:
- C27H44
- Structure:
- Chemical Name:
- cis-Vitamin K2
- CAS:
- 65061-19-0
- MF:
- C31H40O2
- Chemical Name:
- N,N'-((5-methylisoxazole-3,4-diyl)bis(3,1-phenylenesulfonyl))dipropionamide disodium salt
- Chemical Name:
- Zanubrutinib Impurity
- Structure:
- Chemical Name:
- (O-Isobutyryl (R)-Fesoterodine
- CAS:
- 1795786-25-2
- MF:
- C30H43NO4
- Chemical Name:
- Cefdinir Degradation Impurity 1
- Chemical Name:
- Cephalexin Impurity C2
- Chemical Name:
- Cefalexin Ethyl Homolog 2 Impurity
- Structure:
- Chemical Name:
- Azlocillin Opern-Ring Impurity
- CAS:
- 96688-41-4
- MF:
- C20H25N5O7S
- Chemical Name:
- Piperacillin Impurity P
- Structure:
- Chemical Name:
- 1,1'-(((2R,2'R,4R,4'R)-4,4'-(oxybis(methylene))bis(2-(2,4-difluoro phenyl)tetrahydrofuran-4,2-diyl))bis(methylene))bis(1H-1,2,4-triazole)
- CAS:
- 2256739-22-5
- MF:
- C28H28F4N6O3
- Chemical Name:
- 8-((R)-1-acryloylpiperidin-3-yl)-10-(4-phenoxyphenyl)-1,10b-dihydropyrazolo[4,3-e]pyrimido[1,2-c]pyrimidin-2(8H)-one
- Structure:
- Chemical Name:
- Levosimendan Impurity 16
- CAS:
- 2290570-69-1
- MF:
- C11H12N2O
- Structure:
- Chemical Name:
- Tolvaptan Impurity 11
- CAS:
- 331947-69-4
- MF:
- C16H14ClNO2
- Structure:
- Chemical Name:
- (S)-2-((R)-2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide
- CAS:
- 2432911-31-2
- MF:
- C11H18N2O3
- Chemical Name:
- Peramivir Impurity 17
- Chemical Name:
- Peramivir Impurity 23
- Structure:
- Chemical Name:
- Silodosin Carboxylic Acid Impurity
- CAS:
- 1431373-77-1
- MF:
- C25H31F3N2O5