Nigella sativa Seed

DEFINITION

The article consists of the dried ripe seeds of Nigella sativa L. (Family Ranunculaceae). It meets the Acceptance criteria under the Assay.

SYNONYMS

Nigella cretica Mill.

Nigella indica Roxb. ex Flem.

Nigella truncata Viv.

POTENTIAL CONFOUNDING MATERIALS

Cuminum cyminum L., dark-seeded cultivar

SELECTED COMMON NAMES

Arabic:  حَبّة سوداء (al-haba-el-sauda), حبة البركة (habat-al-baraka) 

Bengali: Kalo jeera, kalojire

Bulgarian: Челебитка, Chelebitka posevna

Chinese: 栽培黑种草, 黑苋蒿, 黑莧蒿

Danish: Sortkommen

Dutch: Zwarte komijn

English: Nigella, black seed, black cumin, black caraway, nutmeg flower, fennel flower, Roman coriander

French: Cumin noir, nigelle cultivée, nigelle de Crète, toute épice

German: Schwarzkümmel

Hebrew: קֶצַח (Ketzah), קֶצַח הגִּנָּה (ketzach hagina)

Indian: Kaalaa jiira, kala jeera, Kala zira, kala zeera, kalaunji, kalonji, krishna jeera (Hindi); krishna jiraka, krishna jeeraka (Sanaskrit); Karun jiragam, karunjeerakam, vengaya vidai, vengaya vidhai (Tamil); Nallajirakara, nella jilakaira, ullithnam (Telugu)  

Italian: Cuminella, erba spezie, gittaione, melanzio domestico

Japanese: クロタネソウ(kuro tanetsou), ニゲラ  (nigera),   ニジェーラ  (nijeera)

Korean: 대회향
Malay: Jintam hitam

Malayalam:  Karun jiragam,  karunjirakam

Polish: Czarnuszka siewna

Portuguese: Nigela, cominho-negro, caminho-reto

Russian: Чернушка посевная (Chernushka posevnaia), hигелла  (nigella)

Spanish: Agenuz, agenuz comun, ajenuz común, arañuel, neguilla

Swedish: Svartkummin

Thai: เทียนดำ (thian dam)

Turskish: Çöreg otu (Çörek otu), karamuk, sehniz

CONSTITUENTS OF INTEREST

Volatile oil

Triterpene saponins

IDENTIFICATION

A. Botanical Characteristics

Macroscopic: The seed is flat, oblong, angular, funnel-shaped, about 2 mm long and 1 mm wide, black in color, and has a rough surface.

Microscopic:

Transverse section: The epidermis consists of a single layer of elliptical, thick-walled cells covered with a papillose cuticle and filled with dark-brown contents; 2–4 layers of thick-walled, tangentially elongated, parenchymatous cells; followed by a reddish-brown pigmented layer composed of thick-walled, rectangular elongated cells; a layer of thick-walled, rectangular or nearly columnar, elongated cells. The endosperm consists of thin-walled, rectangular or polygonal cells mostly filled with oil globules.

B. Thin-Layer Chromatography

CALL FOR SUBMISSION OF VALIDATED INFORMATION

Additional information including validation data will be required to complete the development of the Identification. For requirements, please see under "Identification" and related sections of the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesguidelines.

Interested parties are encouraged to submit their proposals to complete the monograph.

ASSAY

• Content of Constituents of Interest

CALL FOR SUBMISSION OF VALIDATED INFORMATION

Additional information including validation data will be required to complete the development of the Assay. For requirements, please see under "Composition" and related sections of the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesguidelines.

Interested parties are encouraged to submit their proposals to complete the monograph.

CONTAMINANTS

• Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>: Meets the requirements

• Microbial Enumeration Tests <61>: The total aerobic bacterial count does not exceed 10⁵ cfu/g, the total combined molds and yeasts count does not exceed 10³ cfu/g, and the bile-tolerant Gram-negative bacteria does not exceed 10³ cfu/g.

• Tests for Specified Microorganisms <62>: Meets the requirements of the tests for the absence of Salmonella species and Escherichia coli

SPECIFIC TESTS

• Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 2.0 %

• Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1 <561>: NLT 7.0%

• Articles of Botanical Origin, Water-Soluble Extractives, Method 2 <561>: NLT 8.0%

• Loss on Drying <731>

Analysis: Dry 3.0 g of Nigella sativa seed, finely powdered, at 105° for 2 h.

Acceptance criteria: NMT 4.0 %

• Articles of Botanical Origin, Total Ash <561>

Analysis: 4.0 g of Nigella sativa seed, finely powdered

Acceptance criteria: NMT 7%

• Articles of Botanical Origin, Acid-Insoluble Ash <561>

Analysis: 6.0 g of Nigella sativa seed, finely powdered

Acceptance criteria: NMT 1.0%

ADDITIONAL REQUIREMENTS

• Packaging and Storage: Preserve in well-closed containers, protected from light and moisture, and store at room temperature.

• Labeling: The label states the Latin binomial and the part of the plant contained in the article.

• USP Reference Standards <11>

(To Come)

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