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:
- Lenvatinib Impurity 18
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 44
- CAS:
- 1048972-52-6
- MF:
- C14H12FNO5
- Chemical Name:
- Nintedanib Impurity 32
- Chemical Name:
- Olsalazine Impurity C
- Chemical Name:
- Parecoxib sodium Impurity 33
- Chemical Name:
- Tofacitinib Impurity 96
- Chemical Name:
- Vildagliptin Impurity ZA5
- Chemical Name:
- Linagliptin Impurity CD10925
- Chemical Name:
- Nintedanib Impurity N
- Structure:
- Chemical Name:
- (2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-(4-chloro-3-(4- hydroxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate
- CAS:
- 1079083-63-8
- MF:
- C27H29ClO10
- Structure:
- Chemical Name:
- Vildagliptin Impurity 25
- CAS:
- 1563006-28-9
- MF:
- C7H10N2O2
- Structure:
- Chemical Name:
- (2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-(4-chloro-3- (4-methoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate
- CAS:
- 872980-38-6
- MF:
- C28H31ClO10
- Structure:
- Chemical Name:
- Vinorelbine Impurity DX
- CAS:
- 89368-94-5
- MF:
- C46H55BrN4O8
- Structure:
- Chemical Name:
- N-(2-(7-methoxy-1,2,3,4-tetrahydronaphthalen-1-yl)ethyl)acetamide
- CAS:
- 178677-49-1
- MF:
- C15H21NO2
- Chemical Name:
- Eltrombopag Impurity 2
- Chemical Name:
- Dapoxetine Impurity 17
- Structure:
- Chemical Name:
- Avibactam Impurity
- CAS:
- 2064219-26-5
- MF:
- C7H12N3NaO6S
- Chemical Name:
- tirofiban Impurity 1 DIHCl
- Structure:
- Chemical Name:
- Fingolimod 2-Phenethyl Analog
- CAS:
- 851039-25-3
- MF:
- C35H57NO2
- Structure:
- Chemical Name:
- Ritonavir EP Impurity O
- CAS:
- 1414933-81-5
- MF:
- C37H48N6O5S2
- Structure:
- Chemical Name:
- Entecavir Impurity 17(Entecavir EP Impurity C)
- CAS:
- 2204369-23-1
- MF:
- C12H15N5O4
- Structure:
- Chemical Name:
- Gemcitabine Impurity 9
- CAS:
- 2174019-90-8
- MF:
- C16H15F2N3O5
- Structure:
- Chemical Name:
- Sacubitril
- CAS:
- 1361408-17-4
- MF:
- C18H20ClNO2
- Chemical Name:
- Empagliflozin Impurity 43
- Structure:
- Chemical Name:
- 1-tosyl-1,4,8,11-tetraazacyclotetradecane trihydrochloride
- CAS:
- 128495-30-7
- MF:
- C17H31ClN4O2S
- Structure:
- Chemical Name:
- (1s,4s)-4-((2-aminobenzyl)amino)cyclohexan-1-ol hydrochloride
- MF:
- C13H21ClN2O
- Chemical Name:
- Solifenacin impurity 23
- Chemical Name:
- Edaravone impurity DEE
- Chemical Name:
- Linagliptin Impurity 49
- Structure:
- Chemical Name:
- (1r,4r)-4-(7,9-dibromo-2,3-dihydro-1H-benzo[e][1,4]diazepin-4(5H)-yl)cyclohexanol hydrochloride
- CAS:
- 2376577-10-3
- MF:
- C15H21Br2ClN2O
- Structure:
- Chemical Name:
- Procatero Impurity
- CAS:
- 90098-93-4
- MF:
- C11H9NO3
- Structure:
- Chemical Name:
- 4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanone hydrochloride
- MF:
- C13H17Br2ClN2O
- Structure:
- Chemical Name:
- Pazufloxacin Impurity 5
- CAS:
- 777824-29-0
- MF:
- C15H15FN2O2
- Chemical Name:
- Vonoprazan Impurity Z-4
- Structure:
- Chemical Name:
- Olanzapine impurity O
- MF:
- C17H20N4S
- Structure:
- Chemical Name:
- Cabozantinib impurity 26
- CAS:
- 2840522-80-5
- MF:
- C28H25ClFN3O5
- Structure:
- Chemical Name:
- Afatinib impurity 45
- CAS:
- 99281-87-5
- MF:
- C5H9NO2
- Structure:
- Chemical Name:
- Dapoxetine impurity 24
- CAS:
- 1445281-20-8
- MF:
- C20H20O4S
- Chemical Name:
- Tazobactam Impurity E
- Chemical Name:
- Vildagliptin Impurity 42
- Chemical Name:
- Canagliflozin Impurity 45
- Chemical Name:
- Pralatrexate Impurity 5
- Chemical Name:
- Pitavastatin Impurity 61
- Chemical Name:
- Sitafloxacin Impurity 17
- Chemical Name:
- Cilastatin Isomer Impurity
- Chemical Name:
- Prednicarbate Impurity E
- Chemical Name:
- Olprinone Impurity B
- Chemical Name:
- Atracurium Impurity 28
- Chemical Name:
- Canagliflozin Impurity 51
- Chemical Name:
- Canagliflozin Impurity 67
- Chemical Name:
- Cefazolin Impurity Q
- Chemical Name:
- Acyclovir Impurity 13
- Chemical Name:
- Afatinib impurity 48
- Chemical Name:
- Linagliptin Impurity L
- Structure:
- Chemical Name:
- Linagliptin Impurity S
- CAS:
- 668273-74-3
- MF:
- C30H36N8O4
- Structure:
- Chemical Name:
- (R)-2-((6-(3-aminopiperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
- MF:
- C17H18FN5O2
- Structure:
- Chemical Name:
- Olaparib impurity 1
- CAS:
- 763113-06-0
- MF:
- C24H24N4O3
- Structure:
- Chemical Name:
- 4-Quinazolinamine,N-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-,hydrochloride(1:1)
- CAS:
- 1624294-38-7
- MF:
- C22H26ClN3O4
- Structure:
- Chemical Name:
- 4-Oxiranylmethoxy-benzaldehyde
- CAS:
- 14697-49-5
- MF:
- C10H10O3
- Structure:
- Chemical Name:
- Alogliptin Related Compound 24
- CAS:
- 1430222-06-2
- MF:
- C14H12ClN3O2
- Chemical Name:
- Apremilast Impurity 1
- Structure:
- Chemical Name:
- Etoricoxib Impurity 15
- CAS:
- 73312-69-3
- MF:
- C5H8ClNO
- Chemical Name:
- Ibrutinib Impurity 1
- Chemical Name:
- Mirabegron Impurity 13
- Chemical Name:
- Riociguat Impurtiy 4
- Structure:
- Chemical Name:
- 2,3-Dehydrosilybin B
- CAS:
- 142796-24-5
- MF:
- C25H20O10
- Structure:
- Chemical Name:
- Cabozantinib Impurity
- CAS:
- 1355031-15-0
- MF:
- C16H14N2O3
- Chemical Name:
- Canagliflozin open-ring impurity
- Chemical Name:
- Dapoxetine Impurity E
- Structure:
- Chemical Name:
- Ilaprazole Impurity
- CAS:
- 1018229-53-2
- MF:
- C11H9N3O
- Chemical Name:
- Linagliptin Impurity X
- Structure:
- Chemical Name:
- Norfloxacin Imp.(EP)
- CAS:
- 1911573-08-4
- MF:
- C34H52FN3O4
- Structure:
- Chemical Name:
- Ondansetron EP Impurity H
- CAS:
- 201409-17-8
- MF:
- C17H18ClN3O
- Structure:
- Chemical Name:
- Rocuronium Bromide Impurity
- CAS:
- 13492-57-4
- MF:
- C27H44N2O4
- Structure:
- Chemical Name:
- Fluconazole
- CAS:
- 163921-62-8
- MF:
- C13H10F2N6
- Structure:
- Chemical Name:
- 4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-amine
- CAS:
- 570407-42-0
- MF:
- C17H23ClN4S2
- Structure:
- Chemical Name:
- Vecuronium Bromide EP Impurity F
- CAS:
- 18668-29-6
- MF:
- C26H41NO3
- Structure:
- Chemical Name:
- Imidafenacin Related Compound 11
- CAS:
- 170105-09-6
- MF:
- C19H17N3
- Structure:
- Chemical Name:
- 4-[3-(Hydroxymethyl)phenoxy]benzonitrile
- CAS:
- 888967-63-3
- MF:
- C14H11NO2
- Structure:
- Chemical Name:
- (S)-3-Boc-5-(benzyloxy)-1-(chloromethyl)-9-methyl-2,3-dihydro-1H-benzo[e]indole
- CAS:
- 945864-47-1
- MF:
- C26H28ClNO3
- Structure:
- Chemical Name:
- Acetaminophen Impurity B
- CAS:
- 98966-17-7
- MF:
- C16H16N2O4
- Structure:
- Chemical Name:
- Furosemide Impurity 2
- MF:
- C12H11ClN2O5S
- Chemical Name:
- Ribavirin Impurity I
- Chemical Name:
- Silodosin Impurity 2
- Chemical Name:
- Tenofovir Impurity 52
- CAS:
- 146297-30-5
- Structure:
- Chemical Name:
- Amifostine Impurity 7
- CAS:
- 174397-83-2
- MF:
- C7H16Br2N2
- Chemical Name:
- Bendamustine Impurity 31
- Structure:
- Chemical Name:
- Carbidopa Impurity 2
- CAS:
- 1361017-74-4
- MF:
- C11H16N2O4
- Chemical Name:
- Cefazolin Impurity 2
- Chemical Name:
- Cefminox Sodium Impurity 8
- Chemical Name:
- Dapagliflozin Impurity 28
- Structure:
- Chemical Name:
- Erlotinib Impurity 51
- CAS:
- 115665-66-2
- MF:
- C8H6BrNO2
- Chemical Name:
- Oseltamivir Impurity 18
- Chemical Name:
- Plerixafor Impurity 6
- Structure:
- Chemical Name:
- Pregabalin Impurity 49
- CAS:
- 1568110-05-3
- MF:
- C10H21NO2
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 79
- CAS:
- 1642601-00-0
- MF:
- C38H38N4O12
- Chemical Name:
- Rocuronium Bromide Impurity 37
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 4
- CAS:
- 1899869-35-2
- MF:
- C19H22FN3O3S