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:
- Labetalone hydrochloride
- CAS:
- 96441-14-4
- MF:
- C19H22N2O3.ClH
- Structure:
- Chemical Name:
- 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dimethyl-7,9-dihydro-8H-purin-8-one
- CAS:
- 1361569-23-4
- MF:
- C20H17FN8O
- Structure:
- Chemical Name:
- 5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol
- CAS:
- 2169153-70-0
- MF:
- C10H15NO4S
- Chemical Name:
- Bendamustine Impurity 14
- Chemical Name:
- Canagliflozin Impurity 28
- Structure:
- Chemical Name:
- Edoxaban Impurity 24 (1S,2S,4R)
- CAS:
- 2024614-21-7
- MF:
- C21H30ClN5O5
- Structure:
- Chemical Name:
- Edoxaban Impurity 39
- CAS:
- 2081883-55-6
- MF:
- C14H27N3O3
- Structure:
- Chemical Name:
- Ezetimibe Impurity 34
- CAS:
- 2280081-69-6
- MF:
- C20H21NO4
- Structure:
- Chemical Name:
- Linagliptin Impurity 33
- CAS:
- 2443735-53-1
- MF:
- C38H42N10O4
- Structure:
- Chemical Name:
- Milrinone Impurity 15
- CAS:
- 156033-07-7
- MF:
- C12H9N3O2
- Chemical Name:
- Milrinone Impurity 6
- Chemical Name:
- Pantoprazole Impurity 2
- Structure:
- Chemical Name:
- rac-Valsartan EP Impurity B
- CAS:
- 1894176-44-3
- MF:
- C31H35N5O3
- Chemical Name:
- Sitafloxacin Dechloro Impurity
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 85
- CAS:
- 1628340-74-8
- MF:
- C28H34F2N6O5S
- Structure:
- Chemical Name:
- Valsartan Impurity 12
- CAS:
- 1189547-11-2
- MF:
- C11H21NO3
- Chemical Name:
- Vonoprazan Impurity 17
- Chemical Name:
- Avibactam Impurity B
- Chemical Name:
- Brexpiprazole Impurity L
- Chemical Name:
- Cefaclor Impurity 4
- Structure:
- Chemical Name:
- Linagliptin Impurity 38
- CAS:
- 1979144-52-9
- MF:
- C20H17ClN6O2
- Chemical Name:
- Pidotimod Impurity N
- Chemical Name:
- Pitavastatin (3S,5S)-Isomer Ethyl Ester
- Chemical Name:
- Pramipexole Impurity 3
- Chemical Name:
- Rupatadine Impurity A
- Chemical Name:
- Sulpiride Impurity 2
- Chemical Name:
- Tenofovir Impurity 55
- Chemical Name:
- Voriconazole Impurity F
- Structure:
- Chemical Name:
- MEDICARPIN-3-O-GLUCOSIDE
- CAS:
- 52766-70-8
- MF:
- C22H24O9
- Structure:
- Chemical Name:
- Atorvastatin Impurity F
- CAS:
- 1371615-56-3
- MF:
- C66H68CaF2N4O10
- Structure:
- Chemical Name:
- Ambroxol Impurity 8(Ambroxol Impurity M)
- CAS:
- 1445719-53-8
- MF:
- C13H16Br2N2O
- Chemical Name:
- Cefdinir impurity PQ mixture
- Structure:
- Chemical Name:
- Loratadine Impurity 16
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Meptazinol BP Impurity D
- CAS:
- 1883577-02-3
- MF:
- C30H44N2O
- Chemical Name:
- Prasugrel Impurity 12
- Chemical Name:
- Pregabalin Impurity 16
- Chemical Name:
- PSI-7977-13C-d3
- CAS:
- 2070009-25-3
- MF:
- C2113CH26D3FN3O9P
- Structure:
- Chemical Name:
- 7-Hydroxy Alosetron
- CAS:
- 863485-44-3
- MF:
- C17H18N4O2
- Structure:
- Chemical Name:
- Dolutegravir 2-Desfluoro Impurity
- CAS:
- 1863916-88-4
- MF:
- C20H20FN3O5
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 46
- CAS:
- 1932499-97-2
- MF:
- C8H16N2
- Structure:
- Chemical Name:
- Posaconazole Impurity 43
- CAS:
- 1428118-40-4
- MF:
- C13H20N2O2
- Structure:
- Chemical Name:
- Empagliflozin Impurity 32
- CAS:
- 1620758-25-9
- MF:
- C24H29ClO8
- Structure:
- Chemical Name:
- Sugammadex Impurity 16
- CAS:
- 2412952-97-5
- MF:
- C69H108BrNaO46S7
- Structure:
- Chemical Name:
- 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride
- MF:
- C14H24Cl2F6N4O2
- Structure:
- Chemical Name:
- 9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid
- CAS:
- 130539-72-9
- MF:
- C19H17FN2O4
- Structure:
- Chemical Name:
- Clopidogrel
- CAS:
- 444728-15-8
- MF:
- C15H15ClN2OS
- Structure:
- Chemical Name:
- (3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II)
- CAS:
- 854898-50-3
- MF:
- C44H54CaF2N6O12S2
- Structure:
- Chemical Name:
- Arbidol Impurity I
- CAS:
- 153633-10-4
- MF:
- C22H24Br2N2O3S
- Structure:
- Chemical Name:
- Palonosetron Impurity 9
- CAS:
- 2216755-75-6
- MF:
- C18H24N2O
- Chemical Name:
- Zopiclone Impurity 12
- Chemical Name:
- Selexipag impurity
- Structure:
- Chemical Name:
- 2-(3-formyl-4-isobutoxyphenyl)-N,N,4-trimethylthiazole- 5-carboxamide
- CAS:
- 1380049-42-2
- MF:
- C18H22N2O3S
- Chemical Name:
- Benidipine Impurity V
- Chemical Name:
- Cefazolin USP Impurity L-△2
- Structure:
- Chemical Name:
- Fluconazole Impurity M
- MF:
- C13H12F2N6O
- Chemical Name:
- Nicorandil Impurity 14
- Chemical Name:
- Ticagrelor Impurity 64
- Chemical Name:
- Ticagrelor Impurity 71
- Structure:
- Chemical Name:
- Tolterodine EP Impurity G
- CAS:
- 1554029-91-2
- MF:
- C22H32NO2+
- Structure:
- Chemical Name:
- Topiroxostat Impurity 23
- CAS:
- 2044706-78-5
- MF:
- C20H12N10
- Structure:
- Chemical Name:
- Saxagliptin Impurity 34
- CAS:
- 2173146-31-9
- MF:
- C17H25NO5
- Chemical Name:
- Afatinib Impurity 25
- Chemical Name:
- Bendamustine Impurity 34
- Chemical Name:
- Canagliflozin Impurity 29
- Structure:
- Chemical Name:
- Cefazolin Impurity 6
- CAS:
- 66636-33-7
- MF:
- C14H20N4O3S3Si
- Structure:
- Chemical Name:
- Ciprofloxacin Impurity 5
- MF:
- C17H18FN3O3
- Structure:
- Chemical Name:
- Erlotinib Impurity 53
- CAS:
- 749181-30-4
- MF:
- C21H25N3O4
- Structure:
- Chemical Name:
- Etoposide Impurity 4
- CAS:
- 101648-60-6
- MF:
- C35H32Cl6O16
- Structure:
- Chemical Name:
- Olaparib Impurity 25
- CAS:
- 1423030-11-8
- MF:
- C16H9FO4
- Chemical Name:
- Olaparib Impurity 32
- Structure:
- Chemical Name:
- Oseltamivir Impurity 23
- CAS:
- 2241125-39-1
- MF:
- C9H16N2O3
- Chemical Name:
- Rosuvastatin Impurity 85
- Structure:
- Chemical Name:
- Amoxicillin Impurity T
- MF:
- C16H19N3O5S
- Chemical Name:
- Apremilast Impurity OH
- Chemical Name:
- Atracurium Impurity T
- Chemical Name:
- Dextrorotation lansoprazole Impurity H
- Chemical Name:
- Dextrorotation lansoprazole Impurity M
- Chemical Name:
- lansoprazole Impurity 26
- Chemical Name:
- Lincomycin sulfone Impurity 2
- Chemical Name:
- Palbociclib Impurity 31
- CAS:
- 2955712-44-2
- Structure:
- Chemical Name:
- Parecoxib Impurity T
- CAS:
- 198471-83-9
- MF:
- C19H18N2O5S
- Chemical Name:
- Ropivacaine Impurity 31
- Chemical Name:
- Ropivacaine Impurity 40
- Chemical Name:
- Sugammadex sodium Decomposition process Impurity 3
- Chemical Name:
- Sugammadex sodium Org48301 Impurity
- Chemical Name:
- Topiroxostat Impurity Ⅱ-3
- Structure:
- Chemical Name:
- Ivabradine related compound 9
- CAS:
- 85175-49-1
- MF:
- C12H13NO4
- Chemical Name:
- Afatinib impurity 28
- Chemical Name:
- blonanserin impurity O
- Structure:
- Chemical Name:
- Butyphthalide impurity 42
- CAS:
- 952412-79-2
- MF:
- C10H12O3
- Chemical Name:
- Butyphthalide impurity 48
- Chemical Name:
- Dapoxetine impurity 20
- Chemical Name:
- Empagliflozin Impurity POE
- Chemical Name:
- Febuxostat Impurity 73
- Chemical Name:
- Febuxostat Impurity 78
- Structure:
- Chemical Name:
- Ibrutinib Impurity 21
- CAS:
- 1642571-08-1
- MF:
- C27H30N6O3
- Chemical Name:
- Lenvatinib Impurity 22
- Chemical Name:
- Moxifloxacin Impurity 47
- Chemical Name:
- Parecoxib sodium Impurity 35
- Structure:
- Chemical Name:
- Tofacitinib Impurity 20
- CAS:
- 1092578-44-3
- MF:
- C27H31N5O2S