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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 CAS MF
Dapoxetine Impurity 4 Dapoxetine Impurity 4
Glycopyrrolate impurity 3 Glycopyrrolate impurity 3
Lamotrigine impurity B Lamotrigine impurity B
Ramosetron Impurity 3 Ramosetron Impurity 3
Loratadine Impurity 1 Loratadine Impurity 1 C22H23ClN2O2
Metoprolol IMpurity 6 Metoprolol IMpurity 6 C15H25NO3
Pitavastatin Impurity 5 Pitavastatin Impurity 5
Prasugrel Impurity C Prasugrel Impurity C
Trifluridine Impurity 2 Trifluridine Impurity 2
Cefazolin Impurity 4 Cefazolin Impurity 4
Vonoprazan Impurity 3 Vonoprazan Impurity 3
Cinacalcene Impurity I Cinacalcene Impurity I
Valsartan Impurity 2 Valsartan Impurity 2 C24H29N5O3
Istradefylline Impurity 2 Istradefylline Impurity 2
Eplerenone Impurity 2 Eplerenone Impurity 2
Etoricoxib Impurity 3 Etoricoxib Impurity 3
Apremilast Impurity 5 Apremilast Impurity 5 200710-04-9 C11H13NO4
Topiroxostat Imp.C Topiroxostat Imp.C
Esmolol Impurity 45 Esmolol Impurity 45
SRI 62320 SRI 62320 94061-80-0 C24H26FNO4.Na
(3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-08-7 C24H21ClFNO3
Rabeprazole Impurity 2 Rabeprazole Impurity 2 1163685-31-1 C11H15NO4
Regorafenib Impurity 8 Regorafenib Impurity 8
Flomoxef Impurity 5 Flomoxef Impurity 5 134237-56-2 C25H23ClF2N2O6S
Ranitidine  impurity Ranitidine impurity 94167-82-5 C10H18N2O
nicergoline impurity E nicergoline impurity E
ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate C26H33NO5
Tacrolimus Impurity C Tacrolimus Impurity C
Levodopa impurity 5 Levodopa impurity 5
2-cyclopentylidene-2-phenylacetic acid 2-cyclopentylidene-2-phenylacetic acid 126497-27-6 C13H14O2
(R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide (R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide 1223404-68-9 C21H22F2N6O2
Afatinib Impurity 18 Afatinib Impurity 18 2316847-95-5 C22H20ClFN4O4
Ivabradine Impurity 1 Hydrochloride Ivabradine Impurity 1 Hydrochloride 85175-52-6 C16H25ClN2O3
SofosBuvir Impurity 3 SofosBuvir Impurity 3
phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate 417722-95-3 C24H18ClN3O5
Canagliflozin Impurity 10 Canagliflozin Impurity 10 1672658-93-3 C24H25FO6S
Canagliflozin Impurity F Canagliflozin Impurity F
Empagliflozin impurity E Empagliflozin impurity E
Fasudil Impurity 6 Fasudil Impurity 6 2044706-58-1 C11H11NO3S
Ibrutinib Impurity 11 Ibrutinib Impurity 11 C27H31N7O2
Nintedanib impurity I Nintedanib impurity I 334951-61-0 C30H31N5O4
(Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid 1253768-91-0 C16H11NO4
Everolimus Related Compound 3 Everolimus Related Compound 3 147438-30-0 C32H49NO9
(R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate (R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate 1627824-09-2 C18H17F5NO5P
Cefuroxime Sodium EP Impurity C Cefuroxime Sodium EP Impurity C 69822-88-4 C15H15N3O6S
Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid 76812-49-2 C23H20ClNO8
Cefuroxime Sodium EP Impurity G Cefuroxime Sodium EP Impurity G 97232-98-9 C17H17N3O8S
2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 1244949-62-9 C11H14ClN3O
Cetirizine 3-Chloro Impurity Cetirizine 3-Chloro Impurity 1232460-31-9 C21H25ClN2O3
Donepezil Impurity 8 Donepezil Impurity 8 1808997-65-0 C18H23NO4
Rivaroxaban Impurity 23 Rivaroxaban Impurity 23
(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide (Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide 1450758-21-0 C5H6N4O2S
Fosfomycin Trometamol impurity C Fosfomycin Trometamol impurity C 23001-39-0 C4H12NO6P
(R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate (R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate C22H23FN2O5
	Olodaterol Impurity 32 Olodaterol Impurity 32
(R)-Lercanidipine Hydrochloride (R)-Lercanidipine Hydrochloride 187731-34-6 C36H42ClN3O6
2-Oxo Clopidogrel Hydrochloride(Mixture of diastereomers) 2-Oxo Clopidogrel Hydrochloride (Mixture of diastereomers) 109904-27-0 C16H16ClNO3S
5-Hydroxy-6-methoxy-1-indanone 5-Hydroxy-6-methoxy-1-indanone 127399-78-4 C10H10O3
Desfluoro Citalopram Oxalate Desfluoro Citalopram Oxalate 1093072-86-6 C22H24N2O5
Didesmethyl Zolmitriptan Didesmethyl Zolmitriptan 139264-15-6 C14H17N3O2
Gabapentin Related Compound E Gabapentin Related Compound E 67950-95-2 C9H14O4
Hydroxy Bosentan Hydroxy Bosentan 253688-60-7 C27H29N5O7S
Lisinopril S,S,S-Diketopiperazine Lisinopril S,S,S-Diketopiperazine 328385-86-0 C21H29N3O4
rac 4-Desmethoxy-4-nitro Omeprazole rac 4-Desmethoxy-4-nitro Omeprazole 317807-10-6 C16H16N4O4S
trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol 201855-60-9 C19H22FNO
ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE 70458-94-5 C14H13ClFNO3
L-Proline, 5-oxo-, compd. with chitosan L-Proline, 5-oxo-, compd. with chitosan 117522-93-7
Dotinurad Impurity 22 Dotinurad Impurity 22 2142685-21-8 C15H14N2S2
Alvatrombopag Impurity 84 Alvatrombopag Impurity 84
Avatrombopag Impurity 60 Avatrombopag Impurity 60
2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 339114-12-4 C7H5ClN2S2
Capecitabine Related Compound B Capecitabine Related Compound B
D-erythro-3,4-Dihydroxyphenylserine D-erythro-3,4-Dihydroxyphenylserine 51829-98-2 C9H11NO5
aztreonam aztreonam 80951-91-3 C13H17N5O8S2
5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 639857-68-4 C14H13NO
[1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) [1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) 76625-61-1 C12H10O6
Oprinone Impurity 6 Oprinone Impurity 6
lamivudine sulfoxide lamivudine sulfoxide 160552-55-6 C8H11N3O4S
Vitamin B12 e-Monocarboxylic Acid Vitamin B12 e-Monocarboxylic Acid 26264-28-8 C63H87CoN13O15P
caffeidine caffeidine 20041-90-1 C7H12N4O
SPLASH? LIPIDOMIX? Mass Spec Standard SPLASH? LIPIDOMIX? Mass Spec Standard
metreleptin metreleptin 186018-45-1
3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 2055-97-2 C13H6I4O4
Sotalol EP Impurity A Sotalol EP Impurity A 16974-42-8 C12H20N2O2S
digoxigenin-mono(digitoxoside) digoxigenin-mono(digitoxoside) 5352-63-6 C29H44O8
N-nitroso-maribavir N-nitroso-maribavir
W 36017 W 36017 21236-54-4 C12H18N2O
ONO EI-601 ONO EI-601 155023-59-9 C15H14N2O6S
norchlorpromazine norchlorpromazine 1225-64-5 C16H17ClN2S
ETHYLISOPROPYLNITROSAMINE ETHYLISOPROPYLNITROSAMINE 16339-04-1 C5H12N2O
1,3,5,7-Tetrmethyl-adamantane 1,3,5,7-Tetrmethyl-adamantane 1687-36-1 C14H24
4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 34523-34-7 C8H9NO2
3-(4,6-diamino-5-((methoxycarbonyl)amino)pyrimidin-2-yl)-5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine 7-oxide 3-(4,6-diamino-5-((methoxycarbonyl)amino)pyrimidin-2-yl)-5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine 7-oxide
Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate 121659-86-7 C20H16FNO2
Silodosin Silodosin 160970-64-9 C25H32F3N3O4
(3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE (3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE 76646-91-8 C8H9Br2NO5S
4-Nitrofluorobenzol 4-Nitrofluorobenzol 352-15-8 C6H4FNO
propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- 144702-27-2 C33H29N5
4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 72570-70-8 C13H19NO4
Fluvoxamino Acid Fluvoxamino Acid 192876-02-1 C14H19F3N2O2
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