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:
- Aprepitant Impurity 44
- CAS:
- 172676-88-9
- MF:
- C23H21F7N4O3
- Chemical Name:
- Oseltamivir Impurity 26
- CAS:
- 241465-24-7
- Chemical Name:
- Afatinib Impurity I
- Chemical Name:
- Moxifloxacin Impurity 5
- Chemical Name:
- Moxifloxacin Impurity 24
- Chemical Name:
- Fosaprepitant Impurity 1
- Chemical Name:
- Ticagrelor Impurity 1
- Chemical Name:
- Ezetimibe Impurity 36
- Chemical Name:
- Pitavastatin Impurity 2
- Chemical Name:
- Fudosteine Impurity 2
- Chemical Name:
- Sugammadex Impurity 18
- Chemical Name:
- Mirabegron Impurity 21
- Structure:
- Chemical Name:
- Apixaban Impurity 18
- CAS:
- 473927-65-0
- MF:
- C20H17IN4O3
- Structure:
- Chemical Name:
- Clopidogrel Impurity 12
- MF:
- C15H14ClNO2S
- Chemical Name:
- Oseltamivir Impurity 25
- Chemical Name:
- Ritonavir EP Impurity P
- Structure:
- Chemical Name:
- Tacrolimus Impurity 4
- CAS:
- 686773-61-5
- MF:
- C44H69NO12
- Structure:
- Chemical Name:
- (2R,4S)-isopropyl5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrolidin-1- yl)-2-methylpentanoate
- MF:
- C25H29NO4
- Structure:
- Chemical Name:
- Taladafil impurity
- CAS:
- 1356345-67-9
- MF:
- C23H23N3O4
- Structure:
- Chemical Name:
- Mirabegron 2-Oxo Impurity
- CAS:
- 1684453-05-1
- MF:
- C21H22N4O3S
- Structure:
- Chemical Name:
- Riluzole 4-Bromo Impurity
- CAS:
- 144631-82-3
- MF:
- C8H4BrF3N2OS
- Structure:
- Chemical Name:
- Furosemide Impurity 8
- CAS:
- 41332-59-6
- MF:
- C7H4Cl2O5S
- Structure:
- Chemical Name:
- Irinotecan Impurity 29
- CAS:
- 797762-11-9
- MF:
- C22H24N2O4
- Chemical Name:
- Empagliflozin Impurity 41
- Chemical Name:
- Empagliflozin Impurity 47
- Structure:
- Chemical Name:
- Irbesartan
- CAS:
- 141745-36-0
- MF:
- C23H26N6O
- Structure:
- Chemical Name:
- Aprepitant
- CAS:
- 170902-80-4
- MF:
- C20H18F7NO2
- Structure:
- Chemical Name:
- Pranoprofen Impurity 5
- CAS:
- 145986-74-9
- MF:
- C16H15NO3
- Structure:
- Chemical Name:
- Fluconazole Impurity
- CAS:
- 1609495-95-5
- MF:
- C15H14FN9O
- Structure:
- Chemical Name:
- 1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)- 1,4,8,11-tetraazacyclotetradecane dodecahydrochloride
- MF:
- C46H96Cl12N12
- Chemical Name:
- Entacapone Impurity 6
- Structure:
- Chemical Name:
- Apremilast Impurity 15
- CAS:
- 2096492-41-8
- MF:
- C22H26N2O8S
- Structure:
- Chemical Name:
- Erythromycin EP Impurity L
- CAS:
- 127955-44-6
- MF:
- C37H65NO14
- Structure:
- Chemical Name:
- Levetiracetam impurity 1
- CAS:
- 1342566-28-2
- MF:
- C8H16N2O3
- Structure:
- Chemical Name:
- methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate hydrochloride
- MF:
- C16H24ClNO5
- Chemical Name:
- Aprepitant iMpurity 37
- Structure:
- Chemical Name:
- Vitamin E Impurity 3
- CAS:
- 1560705-69-2
- MF:
- C29H50O2
- Structure:
- Chemical Name:
- (trans)-phenyl3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)piperidine-1-carboxylate
- MF:
- C32H28FNO5
- Chemical Name:
- arformoterol tartrate impurity
- Chemical Name:
- Cefraprazole impurity
- Chemical Name:
- Afatinib Impurity QAQ
- Structure:
- Chemical Name:
- Afatinib Impurity SHO
- CAS:
- 2223677-65-2
- MF:
- C38H30Cl2F2N8O6
- Structure:
- Chemical Name:
- Androstan-17-one,3-[[(4-methylphenyl)sulfonyl]oxy]-,(3,5)-
- CAS:
- 10429-07-9
- MF:
- C26H36O4S
- Structure:
- Chemical Name:
- Cabozantinib Impurity 48
- CAS:
- 202916-99-2
- MF:
- C17H15NO3
- Chemical Name:
- Landiolol impurity R
- Structure:
- Chemical Name:
- 6-Oxo-Palonosetron
- CAS:
- 848074-10-2
- MF:
- C19H22N2O2
- Chemical Name:
- Teneligliptin Impurity 8
- Structure:
- Chemical Name:
- 2,4(1H,3H)-Pyrimidinedione, 3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl-
- CAS:
- 2354391-45-8
- MF:
- C13H10F4N2O2
- Structure:
- Chemical Name:
- Cyclopropane, nitroso-
- CAS:
- 28017-92-7
- MF:
- C3H5NO
- Chemical Name:
- Hyoscine Butylbromide EP Impurity D
- Chemical Name:
- Carbetocin Impurity 1
- Chemical Name:
- Carboprost Trometamol Impurity A
- Structure:
- Chemical Name:
- Procaine Impurity 2
- MF:
- C13H20N2O2
- Structure:
- Chemical Name:
- 2-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)acetohydrazide hydrochloride
- CAS:
- 1485732-85-1
- MF:
- C8H11F3N6O
- Structure:
- Chemical Name:
- (R)-N-(1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo- 1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)formamide
- CAS:
- 2087874-91-5
- MF:
- C19H20FN5O3
- Chemical Name:
- Abiraterone Impurity 12
- Chemical Name:
- Atracurium Impurity O
- Chemical Name:
- Emtricitabine Impurity F
- Structure:
- Chemical Name:
- Pitavastatin Impurity 44
- CAS:
- 586966-55-4
- MF:
- C29H32FNO4
- Chemical Name:
- Tirofiban Impurity F
- Chemical Name:
- Tofacitinib Impurity 74
- Chemical Name:
- Tofacitinib Impurity 83
- Structure:
- Chemical Name:
- Apixaban Impurity 31
- CAS:
- 2458079-10-0
- MF:
- C27H30N4O6
- Chemical Name:
- Apixaban Impurity 38
- Chemical Name:
- Atracurium Impurity 4
- Chemical Name:
- Aztreonam Impurity 4
- Structure:
- Chemical Name:
- Bendamustine Impurity 29
- CAS:
- 847588-86-7
- MF:
- C19H22N6
- Chemical Name:
- Bendamustine Impurity 35
- Chemical Name:
- Cefoxitin Impurity 3
- Chemical Name:
- Doripenem Impurity 5
- Chemical Name:
- Erlotinib Impurity 47
- Structure:
- Chemical Name:
- Etoposide EP Impurity A
- CAS:
- 124151-67-3
- MF:
- C37H38O15
- Chemical Name:
- Lamivudine Impurity 5
- Structure:
- Chemical Name:
- Lercanidipine Impurity 25
- CAS:
- 100427-22-3
- MF:
- C36H41N3O6
- Chemical Name:
- Oseltamivir Impurity 30
- Structure:
- Chemical Name:
- Pitavastatin Impurity 25
- CAS:
- 1356998-79-2
- MF:
- C19H16FN
- Chemical Name:
- Rocuronium Bromide Impurity 16
- Chemical Name:
- Rocuronium Bromide Impurity 25
- Structure:
- Chemical Name:
- Telmisartan Impurity 5
- CAS:
- 885046-20-8
- MF:
- C19H19ClN4
- Structure:
- Chemical Name:
- Tinidazole Impurity 2
- CAS:
- 140165-55-5
- MF:
- C6H12N2O4S
- Structure:
- Chemical Name:
- 3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one hydrochloride
- CAS:
- 1086026-38-1
- MF:
- C27H34N2O5*ClH
- Structure:
- Chemical Name:
- Amoxicillin Impurity Z
- MF:
- C16H19N3O5S
- Chemical Name:
- Atracurium Impurity P
- Chemical Name:
- Atracurium Impurity U
- Chemical Name:
- Ceftazidime side chain Impurity
- Chemical Name:
- Linagliptin Impurity 35
- Chemical Name:
- Ropivacaine Impurity 1
- Chemical Name:
- Ropivacaine Impurity 46
- Chemical Name:
- Sugammadex sodium Org199425-1 Impurity
- Chemical Name:
- Sugammadex sodium Org244517-1 Impurity
- Structure:
- Chemical Name:
- Terbutaline Impurity 11
- CAS:
- 2387020-93-9
- MF:
- C8H7BrO3
- Structure:
- Chemical Name:
- (2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((R)-tetrahydrofuran- 3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H- pyran-3,4,5-triol
- MF:
- C23H27ClO7
- Structure:
- Chemical Name:
- Afatinib impurity 34
- CAS:
- 2475095-50-0
- MF:
- C14H7ClF2N4O2
- Structure:
- Chemical Name:
- Avibactam Impurity 39
- CAS:
- 2089462-91-7
- MF:
- C15H22N2O3
- Chemical Name:
- Butyphthalide impurity 28
- Structure:
- Chemical Name:
- Butyphthalide impurity 36
- CAS:
- 2245275-82-3
- MF:
- C15H18O5
- Chemical Name:
- Canagliflozin Impurity 32
- Chemical Name:
- Carbocistein Impurity B
- Structure:
- Chemical Name:
- Celecoxib Impurity 22
- CAS:
- 921617-76-7
- MF:
- C17H13F3N2O3S